A Study to Evaluate the Edwards PASCAL Transcatheter Valve Repair System in Patients with Tricuspid Regurgitation

Overview

About this study

The purpose of this study is to establish the safety and effectiveness of the Edwards PASCAL Transcatheter Tricuspid Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria: 

  • Eighteen (18) years of age or older.
  • Patient is deemed symptomatic despite medical therapy and confirmed by the local Heart Team.
  • Severe or greater tricuspid regurgitation.
  • New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months.
  • Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team.
  • Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements.

Exclusion Criteria:

  • Tricuspid valve anatomy not evaluable by TTE and TEE.
  • Tricuspid valve anatomy precludes proper device deployment and function.
  • Patient with refractory heart failure requiring advanced intervention (i.e., left ventricular assist device, transplantation) (ACC/AHA Stage D heart failure).
  • Primary non-degenerative tricuspid disease.
  • Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL.
  • 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.
  • Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
  • Active endocarditis.
  • Continuous home oxygen for primary severe COPD.
  • Pregnant or planning pregnancy within the 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20480300

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