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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05682066
Other study ID # INVL21-01-GE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date January 1, 2025

Study information

Verified date March 2024
Source Innovalve Bio Medical Ltd.
Contact Director Clinical Affairs
Phone +972-3-5308058
Email clinicaltrials@innovalemed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Innovalve MR system
Innovalve MR system

Locations

Country Name City State
Georgia Tbilisi Heart and Vascular Clinic Tbilisi

Sponsors (1)

Lead Sponsor Collaborator
Innovalve Bio Medical Ltd.

Country where clinical trial is conducted

Georgia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absence of implant or delivery related serious adverse events at 30 days Absence of implant or delivery related serious adverse events 30 days
Secondary Technical success 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. Procedure
Secondary 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:
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
30 days
Secondary NYHA functional class 30 days, 6, 12 months and annually up to 5 years
Secondary Six-minute walk test 30 days, 6, 12 months and annually up to 5 years
Secondary Quality of life improvement (KCCQ-12) Kansas City Cardiomyopathy Questionnaire 30 days, 6, 12 months and annually up to 5 years
Secondary Reduction in Mitral Regurgitation grade 30 days, 6, 12 months and annually up to 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT04919980 - TVMR With the Innovalve System Trial - Early Feasibility Study Phase 1
Recruiting NCT05688514 - TVMR With the Innovalve System Trial - First In Human Israel N/A
Not yet recruiting NCT05263375 - TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE N/A
Recruiting NCT05010746 - TVMR With the Innovalve System Trial - Pilot Study in Italy N/A
Active, not recruiting NCT02718001 - Edwards EVOQUE Eos MISCEND Study N/A