Open Actively Recruiting

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

About

Brief Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter 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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Eighteen (18) years of age or older
  • Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
  • 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, or having required, 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

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Study Stats
Protocol No.
21-000321
Category
Cardiology
Principal Investigator
Marcella Calfon Press
Contact
Ladda Douangvila-Chhan
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04097145
For detailed technical eligibility, visit ClinicalTrials.gov.