Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study

Mitral Valve Regurgitation Clinical Trial

— PRELUDE  

Official title:

Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02768402
• Other study ID #: 001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2023

Study information

• Verified date: January 2020
• Source: Caisson Interventional LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

Description:

The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. Further, recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary MR patients. However, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on pump, open-heart procedures. Percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. Percutaneous mitral valve (MV) replacement offers similar advantages. Currently, the only approved percutaneous treatment for MR is MitraClip. MitraClip is limited to a specific population of high risk surgical patients with valvular prolapses that are amenable to repair by the edge to edge technique. The feasibility of percutaneous MV replacement has been shown in animal studies, the implantation of aortic valves at the mitral position, and early evaluations of purpose made transcatheter MVs in humans. To meet this medical need, Caisson Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. As with patients with aortic valve (AV) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. This study will provide initial information on the safety and performance of this system.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has severe mitral regurgitation

• New York Heart Association (NYHA) Class II, III, IVa or heart failure

• High risk for cardiovascular surgery

Exclusion Criteria:

• Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass

• Left ventricular end diastolic dimension > 7cm

• Left ventricular outflow tract obstruction

• Severe right ventricular dysfunction

• Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Caisson TMVR System
Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	OhioHealth	Columbus	Ohio
United States	Delray Medical Center	Delray Beach	Florida
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Saint Thomas Heart	Nashville	Tennessee
United States	New York University Langone Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Swedish Health Services	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Caisson Interventional LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients without Major Adverse Events (MAEs)	Freedom from major adverse events including death, stroke, myocardial infarction and surgical reintervention through 30 days	30 days
Secondary	Number of patients with successful delivery and implantation of the prosthetic valve (technical success)	Successful delivery and retrieval of the transcatheter mitral valve delivery system; deployment and correct positioning (via intraoperative imaging) in the appropriate anatomic location of prosthetic valve with no requirement for additional surgery	Intraoperative
Secondary	Number of living, stroke-free patients with prosthetic valve in place (device success)	Patient is alive, stroke-free, original intended device in place (echo), no mitral valve surgical re-intervention required	30 days