Edwards PASCAL CLASP IID Pivotal Clinical Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:November 30, 2018
End Date:July 31, 2026
Contact:Edwards TMTT Clinical Affairs
Email:TMTT_Clinical@edwards.com
Phone:(949) 250-2500

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

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Mitral Valve
Repair System in patients with degenerative mitral regurgitation (DMR) and who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

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

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

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.

- 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

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

- End-stage Heart Failure with inotrope support or consideration for LVAD or heart
transplant

- 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

- Active rheumatic heart disease or rheumatic etiology for MR

- Severe aortic stenosis or regurgitation

- Known history of severe symptomatic carotid stenosis

- History of 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
We found this trial at
12
sites
New York, New York 10032
Principal Investigator: Susheel Kodali
Phone: 347-514-3366
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Roger Laham, MD
Phone: 617-632-8956
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Abhijeet Dhoble, MD
Phone: 713-500-5214
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Howard Hermann, MD
Phone: 215-615-3265
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Firas Zahr, MD
Phone: 503-494-9114
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: David Scott Lim, MD
Phone: 434-982-1058
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Mark Ricciardi, MD
Phone: 312-926-4000
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Chicago, IL
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: William O'Neil, MD
Phone: 313-916-7430
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Morristown, New Jersey 07962
Principal Investigator: Robert Kipperman, MD
Phone: 973-971-5951
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462 1st Avenue
New York, New York 10010
Principal Investigator: Mathew Williams, MD
Phone: 212-263-4188
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New York, New York 10028
Principal Investigator: Chad A Kliger, MD
Phone: 212-434-4916
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Washington, District of Columbia
Principal Investigator: Vinod Thourani, MD
Phone: 202-877-0078
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