| CTRI Number |
CTRI/2025/05/086586 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study will check how safe and effective a new aortic valve made from dry tissue is for patients with severe heart valve problems who need surgery. The goal is to see how well this new valve works in real-life situations. |
|
Scientific Title of Study
|
An Open label Study, to establish the Safety and Performance Outcome of Surgical Aortic Valve with Dry Tissue in Patients with Aortic Incompetence (AS/AR) via Surgical Method. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-SAVRDRY-2024 Version 3.0 dated 31-Jul-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar Agarwal |
| Designation |
Senior Consultant |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
Maharaja Agrasen Hospital, Department of Cardiology, West Punjabi Bagh, New Delhi-110026, India
New Delhi
DELHI
110026
India |
| Phone |
9910996627 |
| Fax |
|
| Email |
annutaru@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
Chief Executive Officer |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka, New Delhi, Delhi
West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
Chief Executive Officer |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka, New Delhi, Delhi
West
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 - 560 058,Karnataka |
|
|
Primary Sponsor
|
| Name |
Onecrea Medical India Pvt Ltd. |
| Address |
Onecrea Medical India Pvt Ltd.,No. 326 2nd Floor, 9th Cross, 4th
phase, P.I.A, Bangalore North, Bangalore - 560 058,Karnataka |
| Type of Sponsor |
Other [Other [Medical Device Company]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Kumar Agarwal |
Maharaja Agrasen Hospital |
Maharaja Agrasen Hospital, Department of Cardiology, 3 UGF 13/41 Essel Appt, West Punjabi Bagh, New Delhi-110026, India
New Delhi
DELHI |
9910996627
annutaru@yahoo.com |
| Dr Ankur Agrawal |
Subharti Medical College And Hospital |
Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh-250005, India
Meerut
UTTAR PRADESH |
9808567850
ankuragr07@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Maharaja Agrasen Hospital Institutional Ethics Committee |
Approved |
| Subharti Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I352||Nonrheumatic aortic (valve) stenosis with insufficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Surgical Aortic Valve
|
Surgical Aortic Valve
Frequency: Once
Duration: Lifetime
Device brand name: Nexcrea Dehydrated Surgical Aortic Valve. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient must be 55 years or older.
2. Patient provides written informed consent and agrees to all follow-ups at clinical investigational sites that are participating in the OneCrea SAVR study.
3. Patient life expectancy is at least 1 year.
4.Diagnosed with aortic disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, 2D
echocardiography, and CBC).
5. The physician considers the patient a candidate for a bioprosthetic heart valve.
6. STS scores should be less than 4 percent (Low Risk)
7. Patient has significant Aortic stenosis or Aortic regurgitation, or patient is subjected for Aortic Valve replacement due to combine aortic lesion (stenosis and regurgitation).
8. Patient anatomy is eligible for SAVR treatment with the investigational device per the Indications in the Instructions for Use.
9. The patient is in a geographic location that will enable the patient to return to the study site for follow-up examinations.
10. The patient or patient’s legal representative signs an informed consent form prior to enrolment.
|
|
| ExclusionCriteria |
| Details |
1. Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled aortic valve replacement surgery.
2. Has renal insufficiency as determined by creatinine (S-Cr) level greater than or equal to 2.5 gram per decilitre 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 abnormal calcium metabolism and hyperparathyroidism.
7. Exhibits left ventricular ejection fraction less than or equal to 30 percent as validated by diagnostic procedure prior to planned valve surgery.
8. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation.
9. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
10. Documented leukopenia (WBC less than 3.5 x 10³ per microlitre), acute anemia (Hgb less than 10.0 gram per decilitre or 6 millimoles per litre) or thrombocytopenia (platelet count less than 50 x 10³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy.
11. Has prior organ transplant or is currently an organ transplant candidate.
12. The patient is currently participating in a study of an investigational drug or device.
13. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study.
14. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material.
15. Requires concomitant left ventricular assist device (LVAD) placement.
16. Currently unable to give voluntary informed consent.
17. A known hypersensitivity or contraindication to bivalirudin, polyetheretherketone (PEEK) material, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.
18. The patient has a malignancy or other disease with a poor 2-year prognosis which may interfere with the ability to conduct follow-up (i.e. metastatic cancer).
19. The patient is a known alcohol or drug abuser.
20. The patient is currently participating in the study of an unapproved drug or device.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety of Aortic Valve |
Baseline, procedure, discharge, 1month, 3
months, 6 months and at 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Performance outcome of Aortic Valve |
Baseline, procedure, discharge, 1month, 3
months, 6 months and at 12 months. |
|
|
Target Sample Size
|
Total Sample Size="3"
Sample Size from India="3"
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)
|
22/05/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 with malfunctioning aortic valve, as determined by the heart team who require replacement of their native aortic valve due to severe, native aortic valve stenosis (AS).The surgical valve is designed to be implanted in the calcified native aortic annulus of patients with severe aortic stenosis via surgical method. The surgical valve consists of 4 components:The stent, bovine pericardial leaflets, PET fabric, and suture. The stent is polyester-covered stent and is injection-moulded using polyetheretherketone (PEEK) material. The stent material is impregnated with barium sulphate to allow for radiographic visualization. The leaflets are cut from bovine pericardial tissue that has been cross-linked using glutaraldehyde and anti-calcification treated to mitigate calcification. The leaflets are assembled into the stent, and then all components are securely sutured together. A sewing ring is formed using the PET fabric on the inflow side of the stent cover to allow the user to suture the Surgical valve in the supra-annular position. The study comprises of following visits: - Visit 1: Screening Visit/Baseline visit. Visit 2: Day of Surgery Visit 3: Day of Discharge (Discharge as per the patient condition and investigator discretion) Visit 4: 1-month post-surgery (± 3 days) Visit 5: 3-month post-surgery (± 3 days) Visit 6: 6 months post-surgery (± 7 days) Visit 7: 12 months post-surgery (± 7 days) |