TVMR With the Innovalve System Trial - First In Human Israel

Edwards Lifesciences1 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Interventions

Innovalve MR systemDEVICE

Innovalve MR system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Locations (1)

The Chaim Sheba Medical Center

Ramat Gan, Israel

Outcomes

Primary Outcomes

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

Absence of implant or delivery related serious adverse events

Time frame: 30 days

Secondary Outcomes

Technical success

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.

Time frame: Procedure

Procedural success

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

Time frame: 30 days

NYHA functional class

Time frame: 30 days, 6, 12 months and annually up to 5 years

Six-minute walk test

Time frame: 30 days, 6, 12 months and annually up to 5 years

Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire

Data from ClinicalTrials.gov

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