Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF)

April 7, 2026 updated by: Edwards Lifesciences

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1247

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Québec, Canada, G1V 4G5
        • Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • St. Pauls Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
      • Cologne, Germany, 50937
        • Herzzentrum Universitätsklinikum Koln
      • Dresden, Germany, 01307
        • Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden
      • Essen, Germany, 45174
        • Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum
      • Giessen, Germany, 35392
        • Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig Universitätsklinik für Kardiologie
      • Mainz, Germany, 55131
        • Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz
      • München, Germany, 81377
        • Medizinische Klinik I LMU München Campus Grosshadern
      • Siegburg, Germany, 53721
        • Helios Klinikum Siegburg
      • Ulm, Germany, 89081
        • ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II
  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Bern
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
      • Phoenix, Arizona, United States, 85016
        • Abrazo Arizona Heart Hospital
      • Tucson, Arizona, United States, 85712
        • TMC HealthCare
    • California
      • La Jolla, California, United States, 92071
        • Scripps Memorial Hospital La Jolla
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Orange, California, United States, 92868
        • UC Irvine
      • Sacramento, California, United States, 95618
        • Sutter Medical Center-Sacramento
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94118
        • Kaiser Permanente San Francisco
      • San Francisco, California, United States, 94109
        • Sutter Bay Area
      • Stanford, California, United States, 94305
        • Stanford University
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital and Medical Center
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32605
        • The Cardiac and Vascular Institute Research Foundation
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai
      • Naples, Florida, United States, 34102
        • NCH Rooney Heart Institute
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont HealthCare
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital and Emory University Hospital Midtown
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Carmel, Indiana, United States, 46290
        • St. Vincent Heart Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham and Woman's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Heart and Vascular Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St.Luke's Hospital of Kansas City
      • St Louis, Missouri, United States, 63110
        • Washington University/Barnes Jewish Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers-RWJMS
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Buffalo, New York, United States, 14203
        • State University of New York at Buffalo
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10032
        • Columbia University Medical Center/New York Presbyterian Hospital
      • New York, New York, United States, 10075
        • Lenox Hill Hospital and North Shore University
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219-2906
        • The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, United States, 17405
        • Wellspan York Hospital
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • CVA Heart Institute Kingsport
      • Memphis, Tennessee, United States, 38138
        • Baptist Memorial Hospital Memphis
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Heart at Saint Thomas West
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77004
        • HCA Houston Healthcare Medical Center
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eighteen (18) years of age or older
  • Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
  • Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
  • Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
  • Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
  • Mitral regurgitation (3+ to 4+) by echo
  • Suitable valve and regurgitant jet morphology
  • Elevated corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
  • LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)

Exclusion Criteria:

  • Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
  • Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
  • Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
  • Clinically significant, untreated coronary artery disease
  • Recent stroke
  • Other severe valve disorders requiring intervention
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
  • Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
  • Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
  • Active rheumatic heart disease or rheumatic etiology for MR
  • Severe aortic stenosis or regurgitation
  • Known history of untreated, severe carotid stenosis
  • Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Severe COPD
  • Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  • Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
  • Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Edwards PASCAL System - CLASP IID
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
Device: Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Other Names:
  • Transcatheter Mitral Valve repair (TMVr)
Active Comparator: Abbott Mitraclip System - CLASP IID
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
Device: Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Other Names:
  • Transcatheter Mitral Valve repair (TMVr)
Experimental: Edwards PASCAL System - CLASP IIF
Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation
Device: Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Other Names:
  • Transcatheter Mitral Valve repair (TMVr)
Active Comparator: Abbott Mitraclip System - CLASP IIF
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation
Device: Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Other Names:
  • Transcatheter Mitral Valve repair (TMVr)
Experimental: Edwards PASCAL System - Single-Arm Registry
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.
Device: Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Other Names:
  • Transcatheter Mitral Valve repair (TMVr)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).
Time Frame: 30 days.
30 days.
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.
Time Frame: 6 months
6 months
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.
Time Frame: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rates of various adverse events
Time Frame: 6 months; 12 months
Rates of various adverse events at 6 and 12 months
6 months; 12 months
Functional Improvement (increase in 6 minute walk test in meters)
Time Frame: 30 days , 6 months, 1 year
Increase in 6 minute walk test in meters
30 days , 6 months, 1 year
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years
Time Frame: 30 days , 6 months, 1 year, 2 year
Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
30 days , 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years
Time Frame: 30 days, 6 months, 1 year, 2 year
Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life
30 days, 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through
Time Frame: 30 days, 6 months, 1 year, 2 year
Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life
30 days, 6 months, 1 year, 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Lim, MD, University of Virginia
  • Principal Investigator: Robert Smith, MD, The Heart Hospital Baylor Plano
  • Principal Investigator: Linda Gillam, MD, Morristown Medical Center
  • Principal Investigator: Vinod Thourani, MD, Piedmont HealthCare
  • Principal Investigator: Paul Grayburn, MD, The Heart Hospital Baylor Plano
  • Principal Investigator: Brian K Whisenant, MD, Intermountain Medical Center
  • Principal Investigator: Jörg Hausleiter, MD, LMU München, Campus Gorsshadern
  • Principal Investigator: Ralph Stephan von Bardeleben, MD, / Universitätsmedizin Mainz- Zentrum für Kardiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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