SAFETY AND PERFORMANCE OF THE TRIALIGN PERCUTANEOUS TRICUSPID VALVE ANNULOPLASTY SYSTEM (PTVAS) FOR SYMPTOMATIC CHRONIC FUNCTIONAL TRICUSPID REGURGITATIO

• Conditions: symptomatic chronic functional tricuspid - leakage of the right heartvalve; 10046973

• Registration Number: NL-OMON45353
• Lead Sponsor: Mitralign Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. >=18 and <=85 years old
2. New York Heart Association (NYHA) Class II, III or ambulatory IV
3. Symptomatic despite Guideline Directed Medical Therapy (GDMT) for at least 1 month; including diuretics
4. The patient is at high risk for open heart valve surgery
5. The heart team recommends tricuspid annuloplasty, in accordance with the recommendations of the 2012 ESC Valve Guidelines
6. Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
7. Patient is willing and able to comply with all specified study evaluations

Exclusion Criteria

1. History of heart transplant
2. Severe uncontrolled hypertension (SBP >= 180 mmHg and/or DBP >= 110 mmHg)
3. Previous tricuspid valve repair or replacement (including artificial valve)
4. Presence of LVAD, trans-tricuspid pacemaker or defibrillator leads
5. Active endocarditis
6. Severe coronary artery disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint: Incidence of all-cause mortality at 30 days. </p><br>