TVMR With the Innovalve System Trial - Pilot in Georgia

Not Applicable

Completed

• Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
• Interventions: Device: Innovalve MR system

• Registration Number: NCT05682066
• Lead Sponsor: Edwards Lifesciences

Brief Summary

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Detailed Description

The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-12
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Clinically significant, symptomatic mitral regurgitation
• High risk for open-heart surgery
• Meets anatomical criteria

Exclusion Criteria

• Unsuitable anatomy
• Patient is inoperable
• EF<25%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Innovalve TMVR System	Innovalve MR system	MV replacement with Innovalve MR system

Primary Outcome Measures

Name	Time	Method
Absence of implant or delivery related serious adverse events at 30 days	30 days	Absence of implant or delivery related serious adverse events

Secondary Outcome Measures

Name	Time	Method
Six-minute walk test	30 days, 6, 1 year
Quality of life improvement (KCCQ-12) Kansas City Cardiomyopathy Questionnaire	30 days, 6, 1 year
Reduction in Mitral Regurgitation grade	30 days, 6, 1 year
Technical success	Procedure	i. Absence of procedural mortality; and ii. Successful access, delivery, and retrieval of the device delivery system; and iii. Successful deployment and correct positioning of the first intended device; and iv. Freedom from emergency surgery or reintervention related to the device or access procedure.
Procedural success	30 days	All of the following must be present: I. Deployment of the device; II. Absence of major device or procedure related serious adverse events, including: 1. Death; 2. Stroke; 3. Life-threatening bleeding (MVARC scale); 4. Major vascular complications; 5. Major cardiac structural complications; 6. Stage 2 or 3 acute kidney injury (includes new dialysis); 7. Myocardial infarction or coronary ischemia requiring PCI or CABG; 8. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h.; 9. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
NYHA functional class	30 days, 6, 1 year

Trial Locations

Locations (1)

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia