| CTRI Number |
CTRI/2025/02/080341 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of epicardial and endocardial suture occlusion surgical techniques for left atrial appendage in patients undergoing mitral valve surgery: A pilot prospective randomized comparative study |
|
Scientific Title of Study
|
A comparison of epicardial and endocardial suture occlusion surgical techniques for left atrial appendage occlusion in patients undergoing mitral valve surgery: A pilot prospective randomized comparative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Sharma |
| Designation |
Academic resident doctor CTVS |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of CTVS AIIMS Rishikesh, A block level 6
Department of CTVS AIIMS Rishikesh, A block level 6
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8818806969 |
| Fax |
|
| Email |
dsds555sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Danishwar Meena |
| Designation |
Associate professor CTVS |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of CTVS AIIMS Rishikesh, A block level 6
Department of CTVS AIIMS Rishikesh, A block level 6
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9873433256 |
| Fax |
|
| Email |
danishaiims77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Sharma |
| Designation |
Academic resident doctor CTVS |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of CTVS AIIMS Rishikesh, A block level 6
Department of CTVS AIIMS Rishikesh, A block level 6
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8818806969 |
| Fax |
|
| Email |
dsds555sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
AIIMS Rishikesh, Veerbhadra road, Rishikesh 249204, Dehradun |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Danishwar Meena |
residential complex AIIMS Rishikesh, Veerbhadra road, Rishikesh, Dehradun |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Danishwar Meena |
All India Institute of Medical Sciences, Rishikesh |
A block level 6 department of CTVS AIIMS Rishikesh
Dehradun
UTTARANCHAL |
9873433256
danishaiims77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Left atrial appendage surgical occlusion |
Left atrial appendage surgical occlusion epicardial v/s endocardial in patients undergoing mitral valve surgery with or without concomitant tricuspid valve surgery |
| Comparator Agent |
Left atrial appendage surgical occlusion |
Left atrial appendage surgical occlusion epicardial v/s endocardial in patients undergoing mitral valve surgery with or without concomitant tricuspid valve surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing mitral valve surgery with or without tricuspid valve surgery above the age of 18 years to 80 years are included |
|
| ExclusionCriteria |
| Details |
Redo Surgery including closed mitral valvotomy
Recent onset cardio-embolic stroke Less than six weeks
Patients requiring concomitant surgical intervention for critical coronary, carotid artery disease.
• Coagulopathy
• Emergency Surgery
• Refusal to participate in the study
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study efficacy of two surgical techniques in complete occlusion of left atrial appendage: epicardial and endocardial occlusion suture occlusion in patients undergoing mitral valve surgery |
to study efficacy of two surgical techniques in complete occlusion of left atrial appendage: epicardial and endocardial occlusion suture occlusion in patients undergoing mitral valve surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare incidence of cardioembolic stroke in patients of both groups
to compare outcomes in incidence of postoperative complications: reoperation for bleeding, acute renal failure, respiratory failure, cerebrovascular accidents, mortality |
total 1 year follow up |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 randomized control trial (pilot study) aims to compare effectiveness of two surgical techniques for left atrial appendage (LAA) occlusion during mitral valve surgery in preventing thromboembolic events and improving clinical outcomes. post-operative atrial fibrillation (POAF) occurs in 20-25% of cardiac surgeries, increasing risk of stroke and mortality. The LAA is responsible for 90% of left atrial thrombi in atrial fibrillation patients, is commonly managed through surgical occlusion or excision. Despite guidelines recommending LAA closure/ occlusion no consensus exists on best technique. This prospective, single blinded RCT will evaluate short term clinical outcomes and long-term thromboembolic risk to identify the optimal LAA management strategy. |