To evaluate the safety and performance of the Bovine Pericardial Tissue Patch
Phase 4
Not yet recruiting
- Conditions
- Health Condition 1: I00-I99- Diseases of the circulatory system
- Registration Number
- CTRI/2024/08/071956
- Lead Sponsor
- Tisgenx, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients undergoing cardiac surgery requiring a patch for intracardiac or extracardiac repair.
Exclusion Criteria
Patients with known allergies to bovine products or pre-existing conditions contraindicating the
use of bovine pericardial patches.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the patch performance in terms of preoperative imaging, surgical handling, postoperative outcomes and follow-up echocardiography <br/ ><br>2. To study the safety in terms of Patch-related complication and Intra & postoperative complications <br/ ><br> <br/ ><br>Timepoint: Postoperatively: <br/ ><br>1. 1 month <br/ ><br>2. 3rd month <br/ ><br>3. 6th month <br/ ><br>4. Last Follow-up 1 year
- Secondary Outcome Measures
Name Time Method To study the effectiveness of the Bovine Pericardial Tissue Patch Handling characteristics, Patient outcome: ICU days, Hospital days, follow-up echo for cardiac surgery patients to look for <br/ ><br>patch integrity & Mortality & reoperation ratesTimepoint: Postoperatively: <br/ ><br>1. 1 month <br/ ><br>2. 3rd month <br/ ><br>3. 6th month <br/ ><br>4. Last Follow-up 1 year