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CTRI Number  CTRI/2024/05/067666 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study on the efficacy and safety of Hydra valve 
Scientific Title of Study   Prospective observational study on the efficacy and safety of Hydra transcatheter aortic valve - AIIMS Hydra Registry 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HYD/AIIMS-001/2023, V1.0, September 21, 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Narang 
Designation  Professor at the Department of Cardiology 
Affiliation  All India Institute of Medical Science 
Address  Department of Cardiology, Cardiothoracic Sciences Center, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810374638  
Fax    
Email  r_narang@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajiv Narang 
Designation  Professor at the Department of Cardiology 
Affiliation  All India Institute of Medical Science 
Address  Department of Cardiology, Cardiothoracic Sciences Center, Ansari Nagar, New Delhi


DELHI
110029
India 
Phone  9810374638  
Fax    
Email  r_narang@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajiv Narang 
Designation  Professor at the Department of Cardiology 
Affiliation  All India Institute of Medical Science 
Address  Department of Cardiology, Cardiothoracic Sciences Center, Ansari Nagar, New Delhi


DELHI
110029
India 
Phone  9810374638  
Fax    
Email  r_narang@yahoo.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Sahajanand Medical Technologies Limited (SMT) 
Address  Sahajanand Estate, Wakhariawadi, Near Dabholi Char Rasta, Ved Road, Surat-395004, India 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajiv Narang  All India Institute of Medical Sciences  Department of Cardiology, Cardiothoracic Sciences Center, Ansari Nagar, New Delhi- 110029
New Delhi
DELHI 		 9810374638

r_narang@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee - All India Institute of Medical Sciences, New Delhi  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  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients affected by symptomatic severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation
2. Full understanding and willing to provide informed consent to study enrolment 
 
ExclusionCriteria 
Details  1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
2. Refusal to provide informed consent to study enrolment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary safety endpoint: Cardiovascular mortality
Primary performance endpoint: Device success 		 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
All-cause mortality (cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality)  30 days, 1, 3, and 5 years 
All stroke  30 days, 1, 3, and 5 years 
Disabling stroke  30 days, 1, 3, and 5 years 
Myocardial infarction  30 days, 1, 3, and 5 years 
Life threatening bleeding  30 days 
Major vascular complication  30 days 
Acute kidney injury  30 days 
New permanent pacemaker implantation due to procedure related conduction abnormalities  30 days, 1, 3, and 5 years 
Coronary artery obstruction requiring intervention  30 days, 1, 3, and 5 years 
Re-hospitalization for procedure- or valve-related causes  30 days, 1, 3, and 5 years 
Mean aortic valve gradient  30 days, 1, 3, and 5 years 
Effective Orifice Area (EOA)  30 days, 1, 3, and 5 years 
Paravalvular leak  30 days, 1, 3, and 5 years 
New York Heart Association (NYHA) functional class  30 days, 1, 3, and 5 years 
Quality-of-life evaluation  30 days, 1, 3, and 5 years 
Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deterioration  30 days, 1, 3, and 5 years 
Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis  30 days, 1, 3, and 5 years 
Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)  30 days, 1, 3, and 5 years 
VARC-3 Type 2–4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns (e.g., clinically apparent leaflet thrombosis)  30 days, 1, 3, and 5 years 
 
Target Sample Size
Modification(s)  		 Total Sample Size="150"
Sample Size from India="150" 
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)   31/05/2024 
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="6"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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   This is an observational, single-center study. Patients will be enrolled at All India Institute of Medical Sciences (AIIMS), New Delhi, India. The aim of this study is to collect clinical, procedural, and follow-up data in order to evaluate the performances of Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) on the short and long-term follow-up (up to 5 years). 
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