NCT03661398

Brief Summary

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).

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
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 20, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

September 5, 2018

Last Update Submit

January 27, 2020

Conditions

Mitral RegurgitationMitral Valve DiseaseMitral Valve FailureMitral DiseaseValve Heart DiseaseValve Disease, Heart

Keywords

Percutaneous mitral valve replacementTrans-septal mitral valve replacementTranscatheter mitral valve replacementTMVRPrimary MRSecondary MRStructural Heart DiseaseHeart FailureDegenerative Mitral Valve DiseaseFunctional Mitral Valve Disease

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)

    Intra-operative

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

    30 days

Study Arms (1)

Transcatheter Mitral Valve Replacement

EXPERIMENTAL

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

Interventions

Transcatheter Mitral Valve ReplacementDEVICE

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.

Also known as: Caisson Transcatheter Mitral Valve Replacement (TMVR) System
Transcatheter Mitral Valve Replacement

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyDiseaseHeart Valve DiseasesHeart Failure

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Mat Williams, M.D.

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

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

September 5, 2018

First Posted

September 7, 2018

Study Start

July 20, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2025

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)