Health Condition 1: I00-I99- Diseases of the circulatory system
Conditions
Interventions
Intervention1: Bovine Pericardial Tissue Patch: Tisgenx’s BPT Patch is intended for use as a surgical patch for
cardiac and vascular reconstruction and repair, soft tissue
deficiency repair, and rei
Sponsors
Tisgenx, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: Patients undergoing cardiac surgery requiring a patch for intracardiac or extracardiac repair.
Exclusion criteria
Exclusion criteria: Patients with known allergies to bovine products or pre-existing conditions contraindicating the use of bovine pericardial patches.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the patch performance in terms of preoperative imaging, surgical handling, postoperative outcomes and follow-up echocardiography 2. To study the safety in terms of Patch-related complication and Intra & postoperative complications Timepoint: Postoperatively: 1. 1 month 2. 3rd month 3. 6th month 4. Last Follow-up 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 patch integrity & Mortality & reoperation ratesTimepoint: Postoperatively: 1. 1 month 2. 3rd month 3. 6th month 4. Last Follow-up 1 year | — |
Countries
India
Contacts
Public ContactDr Vishal V Bhende
Bhanubhai and Madhuben Patel Cardiac Centre
Outcome results
None listed