Caisson Transcatheter Mitral Valve Replacement (TMVR) (INTERLUDE)

Clinical Investigation of the Caisson Transcatheter Mitral Valve Replacement (TMVR) System for Percutaneous Mitral Valve Replacement in Patients With Symptomatic Mitral Regurgitation

The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

Study Overview

• Status: Active, not recruiting
• Conditions: Mitral Regurgitation; Valve Disease, Heart; Valve Heart Disease; Mitral Valve Disease; Mitral Valve Failure; Mitral Disease
• Intervention / Treatment: Device: Transcatheter Mitral Valve Replacement

Detailed Description

The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. 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. The feasibility of percutaneous MV replacement has been demonstrated in early feasibility studies. 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 information on the safety and performance of this system.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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; transient ischemic attack or myocardial infarction within 30 days of the index procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Mitral Valve Replacement; Patients with symptomatic mitral regurgitation (garde 3 or 4), determined to be a high risk for cardiovascular surgery, will be treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System	Device: Transcatheter Mitral Valve Replacement; All eligible patients will be in the treatment arm for treatment with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System. There is no control (comparator) arm for this study.; Other Names: Caisson Transcatheter Mitral Valve Replacement (TMVR) System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intra-operative
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

Collaborators and Investigators

• Sponsor: Caisson Interventional LLC
• Investigators: Principal Investigator: Mat Williams, M.D., NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; TMVR; Structural Heart Disease; Degenerative Mitral Valve Disease; Percutaneous mitral valve replacement; Trans-septal mitral valve replacement; Transcatheter mitral valve replacement; Primary MR; Secondary MR; Functional Mitral Valve Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Mitral Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: INT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes