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CTRI Number  CTRI/2024/01/061426 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 02/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Transcatheter Aortic Valve Implantation]  
Study Design  Single Arm Study 
Public Title of Study   Study to evaluate safety and efficacy of TAVI -Transcatheter Aortic Valve (Crea Aortic Valve) 
Scientific Title of Study   A prospective, multi-centre, single arm, pivotal clinical study to determine the safety and effectiveness of Crea Aortic Valve for use as a Replacement Aortic Heart Valve 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CT-CE-CREAVALVE-2023 version 1.0 dated 24-Jul-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praveen Chandra 
Designation  Chairman- Interventional Cardiology, Medanta - The Medicity, Gurgaon 
Affiliation  Medanta - The Medicity, Gurgaon 
Address  Sector 38, CH Bakhtawar Singh Road, Islampur Colony, Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9810125370  
Fax    
Email  praveen.chandra@medanta.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Chandra 
Designation  Chairman- Interventional Cardiology, Medanta - The Medicity, Gurgaon 
Affiliation  Medanta - The Medicity, Gurgaon 
Address  Sector 38, CH Bakhtawar Singh Road, Islampur Colony, Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9810125370  
Fax    
Email  praveen.chandra@medanta.org  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Kumar 
Designation  Chief Executive Officer 
Affiliation  CliniExperts Research Services 
Address  Plot No. 5, Unit No. 325, City Centre Mall, Sector 12 Dwarka, Dwarka, New Delhi, Delhi 110075

New Delhi
DELHI
110075
India 
Phone  9999219448  
Fax    
Email  ashwini.kumar@cliniexpertsresearch.com  
 
Source of Monetary or Material Support  
Onecrea Medical India Pvt Ltd. No.326 2nd Floor, 9th Cross, 4th phase, P.I.A, Bangalore North, Bangalore - 560 068, Karnataka 
 
Primary Sponsor  
Name  Onecrea Medical India  
Address  Onecrea Medical India Pvt Ltd. No.326 2nd Floor, 9th Cross, 4th phase, P.I.A, Bangalore North, Bangalore - 560 068, Karnataka 
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 = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Kumar Chaurasia  Artemis Hospital  Clinical Research Department, HR building 4th floor, Sector-51, Gurugram, Haryana-122001
Gurgaon
HARYANA 		 9910643755

amitkumarchaurasia@gmail.com 
Dr Bhagya Narayan Pandit  Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital  Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI 		 9350188470

bnpandit1977@gmail.com 
Dr Bishav Mohan  Dayanand Medical College  Department of Cardiology, Dayanand Medical College and Hospital, Civil Lines, Ludhiana
Ludhiana
PUNJAB 		 9876741158

bishav_68@yahoo.co.in 
Prof S K Dwivedi  King Georges Medical University  Department of Cardiology, King Georges Medical University, Lucknow, Uttar Pradesh-226003
Lucknow
UTTAR PRADESH 		 9935037620

drskdwivedi60@gmail.com 
Dr Santosh Kumar Sinha  LPS Institute of Cardiology & Cardiac Surgery  Room NO. 13, 3rd Floor, LPS Institute of Cardiology & Cardiac Surgery, G.T. Road, Rawatpur, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH 		 9670220088

fionasan@rediffmail.com 
Dr Vijay Kumar Trehan  Maharaja Agrasen Hospital  Department of Cardiology,Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, 110026
West
DELHI 		 9718599102

trehanvs@yahoo.co.in 
Dr Praveen Chandra  Medanta-The Medicity  Department ofInvasive Cardiology, Cardio Division, Sector 38, CH Bakhtawar Singh Road, Islampur Colony, Gurgaon, Haryana-122001
Gurgaon
HARYANA 		 9810125370

praveen.chandra@medanta.org 
Dr Manik Chopra  Narayana Hospital  Dept of Clinical Research, Room no 02, Narayana Multispeciality Hospital, Opposite Rakhiyal Police Station, Rakhiyal Cross Road, Ahmedabad-380023, Gujarat, India
Ahmadabad
GUJARAT 		 7874867383

manikchopra2003@gmail.com 
Dr Siddhant Bansal  SSB Heart and Multispeciality Hospital  Plot No. 69, Mathura Road, Near Neelam Flyover, Sector 20 A, Near Industrial Town, Faridabad, Haryana-121001
Faridabad
HARYANA 		 8590586185

siddhantbansal1991@gmail.com 
Dr Amit Sharma  Subharti Medical College And Hospital  Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh-250005, India
Meerut
UTTAR PRADESH 		 9911053994

dramit97@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Artemis Health Sciences Institutional Ethics Committee  Approved 
Drug Trial Ethics Committee  Approved 
Ethics Committee, PGIMER, Dr. RML Hospital  Approved 
GeneBandhu  Approved 
IEC LPS Institute of Cardiology  Approved 
Institutional Ethics Committee King Georges Medical University  Approved 
Institutional Ethics Committee Maharaja Agrasen   Approved 
Institutional Ethics Committee Subharti Medical College And Hospital  Approved 
Medanta Institutional Ethics Committee (MIEC)  Approved 
Sangini Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Crea Aortic Valve  Crea Aortic Valve Self Expanding Transcatheter Aortic Valve Frequency- Once Duration- Lifetime  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female at least 18 years of age.
2. Patient provides written informed consent and agrees to all follow-up.
3. Patient life expectancy at least 1 year.
4. Subjects with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.
5. Patient anatomy is eligible for TAVR treatment with the investigational device per the Indications in the Instructions for Use. The patient’s aortic arch anatomy requirements are as per communication with the Investigator during training. Patient must present the aortic arch of greater than 80 mm diameter or 100 mm shaft should be able to fit in a straight line in the aorta at the arch. 
 
ExclusionCriteria 
Details  1. Mechanical or biologic prosthesis in the aortic position.
2. Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated.
3. Known allergy to any device component.
4. Bicuspid aortic valve
5. Ongoing sepsis, including active endocarditis
6. Pregnant (female of childbearing potential only).
7. Patient ejection fraction <35%.
8. Patient expected to undergo for coronary intervention within 12 Months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Device Related:
1. Technical Success at exit from procedure room.
2. Device Success at 30 days, or in-hospital if 30-day data are not available.
3. Early Safety at 30 days.
4. Clinical Efficacy at 3-months
5. Clinical Efficacy at 6-months
6. Clinical Efficacy at 12-months.
All cause mortality in 30 days.
 		 30 days, 1 month, 3 month , 6 month and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Patient-Reported Outcomes:
1. NYHA Class (at each follow-up, & change from baseline).
2. 6-Minute Walk Test (6MWT [at 6-Mo & 12-Mo, & change from baseline]).
3. Kansas City Cardiomyopathy Questionnaire (KCCQ [at 12-Mo, with change from baseline]). 		 30 days, 1 month, 3 month , 6 month & 12 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   To evaluate safety and performance outcomes following treatment with the study device in subjects at high surgical risk, as determined by the heart team who require replacement of their native aortic valve due to symptomatic, severe, aortic valve stenosis (AS).High surgical risk is defined as predicted risk of surgical mortality ≥8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator. The total planned study duration is 20 months, which includes an initial recruitment period of 6 months and follow-up period of 12 months and 02-month’s time for post study analysis and site close outs. 
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