Edwards CLASP TR EFS

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Tricuspid Regurgitation

Treatments: Device: Edwards PASCAL Transcatheter Valve Repair System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03745313

2018-10

Details and patient eligibility

About

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Full description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe functional or degenerative TR
• Symptomatic despite medical therapy
• The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair

Exclusion criteria

• Unsuitable anatomy
• Previous tricuspid valve repair or replacement
• Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment with the Edwards PASCAL Transcatheter Valve Repair System

Treatment:

Device: Edwards PASCAL Transcatheter Valve Repair System