Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Recruiting N/A Interventional Study
Tricuspid Regurgitation Functional
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Cardiac Implants LLC · Industry
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About This Trial

An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines. 2. Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to …
Contacts

Nodar Kipshidze, MPH

1-917-370-6247

Nodar@cardiac-implants.com

CONTACT