TWIST-FIHIL: TVMR With the Innovalve System Trial - First In Human Israel
Study Details
Study Description
Brief Summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Innovalve TMVR System MV replacement with Innovalve MR system |
Device: Innovalve MR system
Innovalve MR system
|
Outcome Measures
Primary Outcome Measures
- 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
- Technical success [Procedure]
All of the below: 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: Death Stroke Life-threatening bleeding (MVARC scale) Major vascular complications Major cardiac structural complications Stage 2 or 3 acute kidney injury (includes new dialysis) Myocardial infarction or coronary ischemia requiring PCI or CABG 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. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
- NYHA functional class [30 days, 6, 12 months and annually up to 5 years]
- Six-minute walk test [30 days, 6, 12 months and annually up to 5 years]
- Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire [30 days, 6, 12 months and annually up to 5 years]
- Reduction in Mitral Regurgitation grade [30 days, 6, 12 months and annually up to 5 years]
Eligibility Criteria
Criteria
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%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Chaim Sheba Medical Center | Ramat Gan | Israel | 5265601 |
Sponsors and Collaborators
- Innovalve Bio Medical Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INVL20-01-IL