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SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation (SAPIEN M3 EFS)

Primary Purpose

Mitral Regurgitation, Mitral Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Edwards SAPIEN M3 System
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Mitral Regurgitation focused on measuring Transcatheter Mitral Valve Replacement, SAPIEN M3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older
  2. MR ≥ 3+
  3. NYHA functional class ≥ II
  4. High risk of cardiovascular surgery
  5. Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
  6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  1. Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
  2. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  3. Significant risk of LVOT obstruction
  4. Severe right ventricular dysfunction
  5. LV Ejection Fraction <30%
  6. Patient is inoperable
  7. Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
  8. Need for aortic, tricuspid or pulmonic valve replacement
  9. Presence of mechanical aortic valve prosthesis
  10. History of cardiac transplantation
  11. History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
  12. Clinically significant untreated coronary artery disease requiring revascularization
  13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
  14. Stroke or transient ischemic attack within 90 days of the procedure
  15. Myocardial infarction within 30 days of the procedure
  16. Active bacterial endocarditis within 180 days of the procedure
  17. Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy
  18. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
  19. Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days.
  20. Irreversible, severe pulmonary hypertension
  21. Patients with renal insufficiency or receiving renal replacement therapy
  22. Liver disease or significantly abnormal liver function test results
  23. Refusal of blood products
  24. Female who is pregnant or lactating
  25. Estimated life expectancy < 12 months
  26. Participating in another investigational drug or device study

Sites / Locations

  • Cedars-Sinai Medical Center Heart Institute
  • California Pacific Medical Center
  • Emory University
  • Evanston/ Northshore University
  • Henry Ford Hospital
  • Mayo Clinic
  • Intermountain Medical Center
  • Sentara Cardiovascular Research Institution
  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TMVR

Arm Description

Subjects will undergo transcatheter mitral valve replacement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction in mitral regurgitation (MR)
Reduction in MR to 0 or 1+

Full Information

First Posted
July 24, 2017
Last Updated
June 6, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03230747
Brief Title
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Acronym
SAPIEN M3 EFS
Official Title
Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
June 16, 2021 (Actual)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Prospective, single-arm, multicenter early feasibility study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation, Mitral Disease
Keywords
Transcatheter Mitral Valve Replacement, SAPIEN M3

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMVR
Arm Type
Experimental
Arm Description
Subjects will undergo transcatheter mitral valve replacement
Intervention Type
Device
Intervention Name(s)
Edwards SAPIEN M3 System
Intervention Description
SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock
Primary Outcome Measure Information:
Title
Technical Success
Description
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
Time Frame
At the end of the procedure
Secondary Outcome Measure Information:
Title
Reduction in mitral regurgitation (MR)
Description
Reduction in MR to 0 or 1+
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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 Active bacterial endocarditis within 180 days of the procedure Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days. Irreversible, severe pulmonary hypertension Patients with renal insufficiency or receiving renal replacement therapy Liver disease or significantly abnormal liver function test results Refusal of blood products Female who is pregnant or lactating Estimated life expectancy < 12 months Participating in another investigational drug or device study
Facility Information:
Facility Name
Cedars-Sinai Medical Center Heart Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Evanston/ Northshore University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Sentara Cardiovascular Research Institution
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V62146
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

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