NCT03230747

Brief Summary

This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

9 active sites

Status
active not recruiting

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 Progress88%
Sep 2017Aug 2027

First Submitted

Initial submission to the registry

July 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

3.8 years

First QC Date

July 24, 2017

Last Update Submit

July 17, 2025

Conditions

Mitral RegurgitationMitral Disease

Keywords

Transcatheter Mitral Valve ReplacementSAPIEN M3

Outcome Measures

Primary Outcomes (1)

  • Technical Success

    Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure

    At the end of the procedure

Secondary Outcomes (1)

  • Reduction in mitral regurgitation (MR)

    30 Days

Study Arms (1)

TMVR

EXPERIMENTAL

Subjects will undergo transcatheter mitral valve replacement

Device: Edwards SAPIEN M3 System

Interventions

Edwards SAPIEN M3 SystemDEVICE

SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock

TMVR

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • MR ≥ 3+
  • NYHA functional class ≥ II
  • High risk of cardiovascular surgery
  • Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if:

  • Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
  • Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  • Significant risk of LVOT obstruction
  • Severe right ventricular dysfunction
  • LV Ejection Fraction \<30%
  • Patient is inoperable
  • Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
  • Need for aortic, tricuspid or pulmonic valve replacement
  • Presence of mechanical aortic valve prosthesis
  • History of cardiac transplantation
  • History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
  • Clinically significant untreated coronary artery disease requiring revascularization
  • Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
  • Stroke or transient ischemic attack within 90 days of the procedure
  • Myocardial infarction within 30 days of the procedure
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Cedars-Sinai Medical Center Heart Institute

Los Angeles, California, 90048, United States

Location

California Pacific Medical Center

San Francisco, California, 94109, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Evanston/ Northshore University

Evanston, Illinois, 60201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Sentara Cardiovascular Research Institution

Norfolk, Virginia, 23507, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V62146, Canada

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyDisease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 26, 2017

Study Start

September 14, 2017

Primary Completion

June 16, 2021

Study Completion (Estimated)

August 1, 2027

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(8)CA(1)