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CTRI Number  CTRI/2017/07/009008 [Registered on: 10/07/2017] Trial Registered Prospectively
Last Modified On: 17/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
Study of Dafodil Pericardial Bioprosthesis in patients who require replacement of their natural or artificial heart valve for evaluation of its safety and performance. 
Scientific Title of Study   A prospective, multi-center, single-arm clinical study to evaluate safety and performance of the Dafodil Pericardial Bioprosthesis in patients who require replacement of their natural or prosthetic aortic or mitral valve. 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
MLS/ Dafodil – 1 Version 3.0.0 dated 17 Nov 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Ashok Thakkar 
Address  Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi

Valsad
GUJARAT
396191
India 
Phone  9879443584  
Fax    
Email  ashok.thakkar@merillife.com  
 
Details Contact Person
Scientific Query
 
Name  Dr Ashok Thakkar 
Address  Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi

Valsad
GUJARAT
396191
India 
Phone  9879443584  
Fax    
Email  ashok.thakkar@merillife.com  
 
Details Contact Person
Public Query
 
Name  Dr Ashok Thakkar 
Address  Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi

Valsad
GUJARAT
396191
India 
Phone  9879443584  
Fax    
Email  ashok.thakkar@merillife.com  
 
Source of Monetary or Material Support  
Meril Life Sciences Pvt. Ltd. Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi-396191, Gujarat, India  
 
Primary Sponsor  
Name  Meril Life Sciences Pvt Ltd  
Address  Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi – 396191, Gujarat, India Valsad GUJARAT 396191 India 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 31  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Devi Prasad Shetty  Narayana Health  Department of Cardiac Surgery, 258/A, Anekal Taluk, Hosur Road, Bommasandra Industrial Area, Bengaluru, Karnataka 560099
Bangalore
 
8027835333

devishetty@nhhospitals.org 
Dr Manoj Kumar Daga  The BM Birla Heart Research Centre  Department of Cardiac Surgery, The BM Birla Heart Research Centre, 1/1, National Library Avenue, Kolkata, West Bengal 700027, India
Kolkata
 
9831441031

drmanojdaga@gmail.com 
Dr Praveen K Varma  Amrita institute of Medical sciences and Research centre  Department of Cardiac Surgery, Amrita institute of Medical sciences and Research centre, AIMS, Ponekkara, Edappally, Ernakulam, Kerala 682041
Ernakulam
 
9633671289

varmapk@gmail.com 
Dr Anil R Jain  EPIC Hospital (Unit of Vatsalya Healthcare LLP)  Department of Cardiac Surgery,Empire Doctor House, Opp. Kargil Petrol Pump, S. G. Highway, Ahmedabad-380060, Gujarat, India.
Ahmadabad
 
9825063284

dranilrjain@yahoo.co.in 
Dr P Chandrasekar  G Kuppuswamy Naidu Memorial Hospital  Department of Cardiothoracic Surgery, A-Block-2nd floor, G Kuppuswamy Naidu Memorial Hospital, Pappanaicken Palayam, Coimbatore, Tamil Nadu- 641037, India
Coimbatore
 
9443047152

chanpad@gmail.com 
Dr Vijay Dikshit  Apollo Hospital  Department of Cardiothoracic Surgery, Jubilee Hills, Hyderabad, Telangana 500032, India
Hyderabad
 
9848055572

drvdixit@hotmail.com 
Dr Vivek Jawali  Fortis Hospital Limited  Department of Cardiothoracic Surgery, 154/9, Bannerghatta Road, Opp to IIM-B, Bangalore 560076, Karnataka, India
Bangalore
 
9880331315

vivek.jawali@gmail.com 
Dr Vijay Shankar  Apollo Hospitals  Department of Cardiovascular and Thoracic Surgery, Apollo Hospitals, 21, Greams Lane, Off Greams Road, Chennai-600006, Tamil Nadu, India.
Chennai
 
9840042624

vjshankar2000@gmail.com 
Dr Zile Singh Meharwal  Fortis Escorts Heart Institute and Research Centre  Department of Cardiovascular Surgery, Fortis Escorts Heart Institute and Research Centre Okhla Road, Opposite Holy Family Hospital, New Delhi-110025, Delhi, India
New Delhi
 
9810149301

zile.meharwal@fortishealthcare.com 
Dr Anurag Garg  Dr. D. Y. Patil Medical College, Hospital and Research Centre  Department of Cardiovascular & Thoracic Surgery, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Pimpri, Sant Tukaram Nagar, Pune-411018, Maharashtra, India
Pune
 
9921999321

gargjunior@hotmail.com 
Dr Nityanand Thakur  Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals  Department of Cardiothoracic Surgery, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Jai Prakash Narayan Road, Near Pune Railway Station, Pune, Maharashtra – 411001, India
Pune
 
9822830642

nityanandt@hotmail.com 
Dr Nirmal Gupta  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Department of Cardiothoracic and Vascular Surgery, Raebareli Road, Lucknow-226014, India
Lucknow
 
9415024422

drnirmalgupta@gmail.com 
Dr C S Hiremath  Sri Sathya Sai Institution of Higher Medical Sciences  Department of Cardiothoracic and Vascular Surgery, Whitefield, Bangalore-560066, Karnataka, India
Bangalore
 
9481119696

cs.hiremath_18@yahoo.co.in 
Dr Ganesh Kumar Mani  Max Smart Super Speciality Hospital  Department of Cardiothoracic and Vascular Surgery, Saket, Mandir Marg, Press Enclave Road, New Delhi-110017, India
New Delhi
 
9811062658

Ganeshk.mani@maxhealthcare.com 
Dr Rajneesh Malhotra  Max Super Speciality Hospital (A Unit of Devki Devi Foundation)  Department of Cardiothoracic and Vascular Surgery, 2, Press Enclave Road, Saket, New Delhi-110017, India
New Delhi
 
9999722781

Rajneesh.malhotra@maxhealthcare.com 
Dr Dhaval Naik  Care Institute of Medical Sciences (CIMS)  Department of Cardiothoracic and Vascular Surgery, Opposite Panchamrut Bunglows, Near Shukan Mall, Off Science City Road, Sola, Ahmedabad-380060, Gujarat, India
Ahmadabad
 
9099111133

dhaval.naik@cims.me 
Dr Suhas Parikh  K J Somaiya Medical College and Hospital  Department of Cardiothoracic and Vascular Somaiya Ayurvihar Complex, Eastern Express Highway, Sion (East), Mumbai, Maharshtra, India
Mumbai
 
9820073918

suhasparikh@gmail.com 
Dr Vijay Gupta  Dr. Ram Manohar Lohia Hospital  Department of Cardiovascular Thoracic Surgery, Baba Kharak Singh Marg, New Delhi-110001, India
New Delhi
 
9810415962

vijayctvs@yahoo.co.in 
Dr Ajeet Bana  Eternal Heart Care Centre & Research Institite Pvt Ltd  Department of CVTS, 3A, Jagatpura Road, Near Jawahar Circle, Jagatpura, Jaipur-302017, Rajasthan, India
Jaipur
 
9829018195

bana_ajeet@yahoo.co.in 
Dr Seetharama Bhta  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Department of Cardiothoracic surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bannerghatta Main Road, Jayanagara 9th Block, Bengaluru, Karnataka 560069, India
Bangalore
 
08022977395

pssbhat@gmail.com 
Dr Shiv Kumar Choudhary  All India Institute of Medical Sciences  Department of Cardiothoracic Surgery, Ansari Nagar, New Delhi, Delhi 110029, India
New Delhi
 
9811763740

shivchoudhary@hotmail.com 
Dr Atul Maslekar  Narayana Multispeciality Hospital  Department of Cardiothoracic and Vascular Surgery, Nr. Chakudiya Mahadev, Rakhial Cross Road, Opp. Rakhial Police Station, Rakhial, Ahmedabad-380023, Gujarat, India
Ahmadabad
 
9723817370

atulmaslekar@hotmail.com 
Dr S Rajan  The Madras Medical Mission   Department of Cardiothoracic and Vascular Surgery, 4-A, Dr. J. Jayalalitha Nagar, Mogappair,Chennai - 600 037, Tamil Nadu, India
Chennai
 
9841271353

drrajan1957@gmail.com 
Dr Prashant Vaijayanath  Kovai Medical Center and Hospital Limited  Department of Cardiothoracic and Vascular Surgery, 99, Avanashi Road, Coimbatore-641014, India
Coimbatore
 
0422-4324530

vaijyanath3@gmail.com 
Dr Anand Sancheti  NewEra Hospital And Research Institute  Department of Cardiothoracic and Vascular Surgery, Lakadganj, Nagpur, Maharashtra 440008, India
Nagpur
 
9325544778

dranandsancheti@gmail.com 
Dr Manish Porwal  CHL Hospitals  Department of Cardiothoracic Surgery, A.B. Road, Near L.I.G Square, Indore, Madhya Pradesh 452008, India
Indore
 
9827055997

mporwal@hotmail.com 
Dr Ajay Kaul  Dr. B. L. Kapur Memorial Hospital  Department of Cardio Thoracic and Vascular Surgery,Dr. B. L. Kapur Memorial Hospital, Pusa Road, New Delhi- 110005
New Delhi
 
9971230999

ajay.kaul@blkhospital.com 
Dr Binay Krishna Sarkar  NRS Medical College and Hospital  Department of Cardiovascular and Thoracic Surgery, NRS Medical College and Hospital, 138 AJC Bose Road, Kokalta-700014
Kolkata
 
9674700136

binayskr@hotmail.com 
Dr T Periyaswami  Sri Ramchandra Institute of Higher Education & Research  Department of Cardiothoracic and Vascular Surgery No.1 Ramachandra Nagar, Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
 
9677239490

Drsamy79@yahoo.com 
Dr S S Rajput  Ram Manohar Lohia Institute of Medical Sciences  Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomati Nagar, Lucknow - 226010
Lucknow
 
8176007067

drssrajput60@gmail.com 
Dr Ritwick Raj Bhuyan  Max Super Specialty Hospital  Department of Cardio thoracic surgery (A unit of Balaji Medical & diagnostic Research Centre), 108 A, I. P. Extention, Patparganj, New Delhi-110092, India
New Delhi
 
09650621777

Drritwick72@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 31  
Name of Committee  Approval Status 
Ethics Committee of CIMS, Ahmedabad  Approved 
Ethics Committee of Shreeji Hospital   Approved 
Institutioal Ethics Committee, B. M. Birla Heart Research Centre, Kolkata  Approved 
Institutional Ethics Committee, Department of Academic Affairs and Continuing Education (AARCE), Dr. B.L.Kapur Memorial Hospital, Pusa Road New Delhi  Approved 
Institutional Ethics Committee, Max Super Specialty Hospital  Approved 
Institutional Ethics Committee - Clinical Studies, Apollo Hospitals, Chennai  Approved 
Institutional Ethics Committee Clinical Studies Apollo Hospitals Hyderabad  Approved 
Institutional Ethics Committee, AIMS, New Delhi  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Centre, Kerala, India  Approved 
Institutional Ethics Committee, B J Medical College and Sassoon General Hospitals, Pune  Approved 
Institutional Ethics Committee, Dr D Y Patil Vidyapeeth, Pune  Approved 
Institutional Ethics Committee, Eternal Heart Care Centre and Research Institute Private Limited, Rajasthan   Approved 
Institutional Ethics Committee, Fortis Escorts Heart Institute, New Delhi  Approved 
Institutional Ethics Committee, Fortis Hospital, Bangalore  Approved 
Institutional Ethics Committee, G Kuppuswamy Naidu Memorial Hospital, Coimbatore   Approved 
Institutional Ethics Committee, K J Somaiya Medical College and Hospital, Mumbai  Approved 
Institutional Ethics Committee, Max Smart Super Speciality Hospital (A Unit of Gujarmal Modi Hospital and Research Centre for Medical Sciences), Saket, New Delhi  Approved 
Institutional Ethics Committee, Max Super Specialty Hospital (A Unit of Devki Devi Foundation), New Delhi, India  Approved 
Institutional Ethics Committee, Narayana Health, Karnataka, India  Approved 
Institutional Ethics Committee, NRS Medical College, Kolkata  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Dr. RML Hospital, New Delhi   Approved 
Institutional Ethics Committee, Ram Manohar Lohia Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow  Approved 
Institutional Ethics Committee, Sri Ramchandra Institute of Higher Education& Research  Approved 
Institutional Ethics Committee, Sri Sathya Sai Institute of Higher Learning, Prasanthi Nilayalam, Andhra Pradesh  Approved 
Institutional Ethics Committee, The Madras Medical Mission, Chennai  Approved 
Integrity Ethics Committee, CHL Hospitals, Indore  Approved 
KMCH Ethics Committee, Coimbatore  Approved 
NewEra Hospital Ethics Committee  Approved 
Sangini Hospital Ethics Committee  Approved 
Sri Jayadeva Institute Ethics Committee, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Rheumatic disorders of both mitraland aortic valves 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dafodil-Pericardial Bioprosthesis  Dafodil-Pericardial Bioprosthesis is used in patients who require replacement of their natural or prosthetic aortic or mitral valve. 
Comparator Agent  NA  Na 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for Aortic Valve:
1. Patient must be 18 years or older.
2. Patient must provide written informed consent prior to study procedures.
3. STS scores should be less than 4 percent (Low Risk)
4. Patient must agree to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the Dafodil-1 study.
5. Diagnosed with aortic disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, echocardiography and CBC).
6.Patient has significant Aortic stenosis or Aortic regurgitation or patient is subjected for Aortic Valve replacement due to combine aortic lesion (stenosis and regurgitation).
(Reference: European society of Cardiology (ESC)/ American Society of Echocardiography (ASE) Guidelines - 2017)
7. Scheduled to undergo planned aortic valve replacement with or without concomitant bypass surgery or other valvular surgeries.


Inclusion Criteria for Mitral Valve:
1. Patient must be 18 years or older.
2. Patient must provide written informed consent prior to study procedures.
3. STS scores should be less than 4 percent (Low Risk)
4. Patient must agree to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the Dafodil-1 study.
5. Diagnosed with mitral valve disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, echocardiography and CBC).
6. Patient has significant Mitral Stenosis or Mitral Regurgitation or patient is subjected for Mitral Valve replacement due to combine mitral lesion (stenosis and regurgitation).
(Reference: European society of Cardiology (ESC)/ American Society of Echocardiography (ASE) Guidelines - 2017)
7. Scheduled to undergo planned mitral valve replacement with or without concomitant bypass surgery or other valvular surgeries.
 
 
ExclusionCriteria 
Details  Exclusion Criteria for Aortic Valve:
A subject meeting any of the following criteria shall be excluded.
1. Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled aortic replacement surgery.
2. Has renal insufficiency as determined by creatinine (S-Cr) level greater than or equal to 2.5 gram per deciliter or end-stage renal disease requiring chronic dialysis at screening visit.
3. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or TIA within 6 months (180 days) prior to planned valve surgery.
4. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery.
5. Has presence of non-cardiac disease limiting life expectancy to less than 5 years.
6. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
7. Diagnosed with abnormal calcium metabolism and hyperparathyroidism.
8. Exhibits left ventricular ejection fraction less than or equal to 20 percent as validated by diagnostic procedure prior to planned valve surgery.
9. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation.
10. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
11. Documented leukopenia (WBC less than 3.5 x 10³ per microlitre), acute anemia (Hgb less than 10.0 grams per deciliter or 6 milimoles per litre) or thrombocytopenia (platelet count less than 50 x 10³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy.
12. Has prior organ transplant or is currently an organ transplant candidate.
13. The patient is currently participating in a study of an investigational drug or device.
14. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study.
15. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material.
16. Requires concomitant left ventricular assist device (LVAD) placement.
17. Currently unable to give voluntary informed consent
18. A known hypersensitivity or contraindication to bivalirudin, nitinol, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.

Exclusion Criteria for Mitral Valve:
A subject meeting any of the following criteria shall be excluded.
1. Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled mitral valve replacement surgery.
2. Has renal insufficiency as determined by creatinine (S-Cr) level greater than or equal to 2.5 gram per deciliter or end-stage renal disease requiring chronic dialysis at screening visit.
3. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or TIA within 6 months (180 days) prior to planned valve surgery.
4. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery.
5. Has presence of non-cardiac disease limiting life expectancy to less than 5 years.
6. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM).
7. Diagnosed with abnormal calcium metabolism and hyperparathyroidism.
8. Exhibits left ventricular ejection fraction less than or equal to 20 percent as validated by diagnostic procedure prior to planned valve surgery.
9. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation.
10. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
11. Documented leukopenia (WBC less than 3.5 x 10³ per microlitre), acute anemia (Hgb less than 10.0 gram per deciliter or 6 milimoles per litre) or thrombocytopenia (platelet count less than 50 x 10³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy.
12. Has prior organ transplant or is currently an organ transplant candidate.
13. The patient is currently participating in a study of an investigational drug or device.
14. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study.
15. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material.
16. Requires concomitant left ventricular assist device (LVAD) placement.
17. Currently unable to give voluntary informed consent.
18. A known hypersensitivity or contraindication to bivalirudin, nitinol, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MACE, Cardiovascular mortality, Stroke and Transient Ischemic Attack (TIA), Major bleeding, Minor bleeding, Acute kidney injury(AKIN classification), Valve thrombosis, Structural valve deterioration, Prosthetic valve Endocarditis, Major paravalvular leak, Conduction disturbances and arrhythmias, Nonstructural valve dysfunction, Mitral valve apparatus damage or dysfunction, Aortic valve apparatus damage or dysfunction, Explant, Hemolysis, Trial valve-related reoperation  Baseline, 1 month, 6 months, 1 year, 2 years,3 years,4 years and 5 years 
 
Secondary Outcome  
Outcome  TimePoints 
NYHA, Quality of life, Hemodynamic performance, Device success  Baseline, 1 month, 6 months, 1 year, 2 years,3 years,4 years ,and 5 years 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/07/2017 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="5"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NA 
Brief Summary  

This is a prospective, multi-center, single-arm clinical study to evaluate safety and performance of the Dafodil Pericardial Bioprosthesis for the replacement of natural or prosthetic aortic or mitral valve in approximately 60 patients (30 patients will be enrolled in prosthetic aortic valve and 30 patients will be enrolled in mitral valve replacement procedure) in India at more than 5 sites.

The main objective of the study is to evaluate safety and performance of the Dafodil Pericardial Bioprosthesis in high risk, symptomatic patients with severe aortic stenosis at different time points [Baseline, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years].

All eligible subjects based on inclusion/exclusion will be approached to sign Informed Consent Form approved by respective Ethics Committee before starting the study related process. Subjects will be kept treated with Dafodil Pericardial Bioprosthesis in patients who require replacement of their natural or prosthetic aortic or mitral valve as per standard guidelines and practices. The subject will be kept on a standard regimen in post operative and follow-up period. Subject’s clinical follow-up will be taken at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.

 

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