Sealing of the pouch attached with left upper chamber of heart during routine cardiac surgery for prevention of brain attack and other diseases caused by blood clots going to other orgnas.

Phase 2/3

Recruiting

• Conditions: having Atrial Fibrillation Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass

• Registration Number: CTRI/2018/02/011925
• Lead Sponsor: Population Health Research Institute

Brief Summary

The primary objective is to examine the impact of LAA occlusion on the incidence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism over the duration of follow-up in patients with atrial fibrillation undergoing cardiac surgery with the use of cardiopulmonary bypass.

The primary clinical hypothesis is that patients who have had their LAA occluded/removed will benefit over those on usual care alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-24
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 4700

Inclusion Criteria

1. Age ≥ 18 years of age 2) Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass 3) A documented history of atrial fibrillation or atrial flutter 4) CHA2DS2-VASc score ≥ 2 5) Written informed consent.

Exclusion Criteria

• 1. Patients undergoing any of the following procedures: a.
• Off-pump cardiac surgery b.
• Heart transplant c.
• Complex congenital heart surgery d.
• Sole indication for surgery is ventricular assist device insertion e.
• Previous cardiac surgery requiring opening of the pericardium f.
• Mechanical valve implantation 2) Patients who have had a previous placement of a percutaneous LAA closure device.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke or systemic arterial embolism	Over the duration of follow-up (five years)
First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism	Over the duration of follow-up (five years)

Secondary Outcome Measures

Name	Time	Method
All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism	median follow-up of 4 years
Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death	Common termination point (median follow-up of 4 years)
Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism 30 days after surgery	Common termination point (median follow-up of 4 years)
All cause death	median follow-up of 4 years

Trial Locations

Locations (6)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Dr. Ram Manohar Lohia Hospital & PGIMER; 🇮🇳 Delhi, DELHI, India

G. Kuppusawmy Naidu Memorial Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

SAL Hospital & Medical Institute; 🇮🇳 Ahmadabad, GUJARAT, India

Sri Chitra Tirunal Institute of Medical Sciences and Technology; 🇮🇳 Thiruvananthapuram, KERALA, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Dr G Karthikeyan

Principal investigator

011-26594464

karthik2010@gmail.com