NCT02768402

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

7.3 years

First QC Date

May 5, 2016

Last Update Submit

January 27, 2020

Conditions

Mitral Valve Regurgitation

Keywords

Mitral Valve RegurgitationPrimary MRSecondary MRMRHeart FailureStructural HeartSecondary Mitral Valve RegurgitationPrimary Mitral Valve RegurgitationTransseptalTranscatheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of patients with successful delivery and implantation of the prosthetic valve (technical success)

    Intraoperative

  • Number of living, stroke-free patients with prosthetic valve in place (device success)

    30 days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All eligible patients will be in the treatment arm for the 'Caisson TMVR System' (transcatheter mitral valve replacement) procedure. No control or comparator in this study.

Device: Caisson TMVR System

Interventions

Caisson TMVR SystemDEVICE

Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.

Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has severe mitral regurgitation
  • New York Heart Association (NYHA) Class II, III, IVa or heart failure
  • High risk for cardiovascular surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OhioHealth

Columbus, Ohio, 43214, United States

Location

Saint Thomas Heart

Nashville, Tennessee, 37205, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Mathew Williams, MD

    NYU Langone Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 11, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(13)