Safety and Performance of the Cardiovalve TR Replacement System

Launched by CARDIOVALVE LTD. · Aug 2, 2022

Keywords

ClinConnect Summary

The Cardiovalve TR Replacement System clinical trial is studying a device designed to help patients with a heart condition called tricuspid regurgitation (TR), where the heart's tricuspid valve doesn't close properly. This trial aims to determine how safe and effective this new system is for treating this condition. It is currently recruiting participants aged between 65 and 74 years, and it is open to all genders. To be eligible for the study, patients must have moderate to severe TR and experience symptoms that affect their daily lives.

Participants who join the trial can expect to undergo assessments to ensure they meet the criteria and receive support throughout the study. However, patients with certain heart issues or unstable health conditions may not qualify. This trial is an important step in finding better treatments for people suffering from tricuspid regurgitation, and it could lead to new options for those who need help managing their symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Functional TR ≥3+
• • Symptomatic, NYHA Class II-IVa
• • Patient approved by the Subject Screening Committee
• Exclusion Criteria:
• • Cardiac anatomy deemed not suitable for the Cardiovalve TR system
• • Hemodynamic instability
• • Severe right ventricular failure
• • Refractory heart failure requiring advanced intervention