NCT03170349

Brief Summary

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
7 countries

17 active sites

Status
completed

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 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 1, 2021

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed
Last Updated

February 5, 2026

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

May 26, 2017

Results QC Date

July 28, 2021

Last Update Submit

January 16, 2026

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Major Adverse Events (MAE)

    Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days post-implant. MAEs during the first year of post-implant follow-up were adjudicated by a Clinical Events Committee of independent heart specialist physicians.

    30 days

  • Device Success

    Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

    Exit from the cardiac catheterization laboratory

  • Number of Participants With Procedural Success

    Device success with evidence of mitral regurgitation reduction to ≤ 2+ (mild-moderate) at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

    through discharge

  • Clinical Success

    Procedural success with evidence of MR reduction to ≤ 2+ (mild-moderate) and without MAEs at 30 days. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

    30 days

Secondary Outcomes (62)

  • Mitral Regurgitation Reduction

    Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

  • All-cause Mortality

    30 days, 6 months, 1 year, 2 years, 3 years, 4 Years

  • Recurrent Heart Failure Hospitalization

    30 days , 6 months, 1 year, 2 year, 3 year, 4 year

  • Reintervention Rates for Mitral Regurgitation

    30 days, 6 months, 1 year, 2 year, 3 year, 4 year

  • Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications.

    6 months, 1 year, 2 year, 3 year, 4 year

  • +57 more secondary outcomes

Study Arms (1)

Edwards PASCAL Transcatheter Mitral Valve Repair System

EXPERIMENTAL
Device: Mitral Valve Repair

Interventions

Mitral Valve RepairDEVICE

Minimal Invasive Transcatheter Mitral Valve Repair

Edwards PASCAL Transcatheter Mitral Valve Repair System

Eligibility Criteria

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

You may qualify if:

  • Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
  • Eighteen (18) years of age or older
  • New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
  • Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
  • Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
  • The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
  • Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.

You may not qualify if:

  • Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
  • Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
  • Mitral valve area (MVA) \< 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  • Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
  • Patient is under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Metro North Hospital & Health Service, The Prince Charles Hospital

Brisbane, Chermside, QLD 4032, Australia

Location

Sydney Local Health District, Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

St. Paul's Hospital, Providence Health Care Research Institute

Vancouver, British Columbia, V6E 1M7, Canada

Location

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael Hospital

Toronto, Ontario, M5B-1W8, Canada

Location

Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie

Bonn, 53127, Germany

Location

Hygeia Hospital

Athens, 15123, Greece

Location

San Rafaelle Hospital

Milan, 20132, Italy

Location

Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

  • Webb JG, Hensey M, Szerlip M, Schafer U, Cohen GN, Kar S, Makkar R, Kipperman RM, Spargias K, O'Neill WW, Ng MKC, Fam NP, Rinaldi MJ, Smith RL, Walters DL, Raffel CO, Levisay J, Latib A, Montorfano M, Marcoff L, Shrivastava M, Boone R, Gilmore S, Feldman TE, Lim DS. 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2344-2357. doi: 10.1016/j.jcin.2020.06.019.

    PMID: 33092709DERIVED

  • Lim DS, Kar S, Spargias K, Kipperman RM, O'Neill WW, Ng MKC, Fam NP, Walters DL, Webb JG, Smith RL, Rinaldi MJ, Latib A, Cohen GN, Schafer U, Marcoff L, Vandrangi P, Verta P, Feldman TE. Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. JACC Cardiovasc Interv. 2019 Jul 22;12(14):1369-1378. doi: 10.1016/j.jcin.2019.04.034. Epub 2019 Jun 26.

    PMID: 31255562DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Results Point of Contact

Title
Ted Feldman
Organization
Edwards Lifesciences
Feldman_Info@edwards.com
949-250-2500

Study Officials

  • Gideon Cohen, MD

    Sunnybrook Hospital

    PRINCIPAL INVESTIGATOR

  • Ulrich Schafer, MD

    BundeswehrZentralkrankenhaus Koblenz

    PRINCIPAL INVESTIGATOR

  • Molly Szerlip, MD

    The Heart Hospital Baylor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

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 26, 2017

First Posted

May 31, 2017

Study Start

June 27, 2017

Primary Completion

July 30, 2020

Study Completion

May 27, 2025

Last Updated

February 5, 2026

Results First Posted

December 1, 2021

Record last verified: 2025-12

Locations

CA(3)IT(1)GR(1)AU(2)CH(1)DE(1)US(8)