Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

  • STATUS
    Recruiting
  • End date
    Sep 6, 2027
  • participants needed
    15
  • sponsor
    Cardiac Implants LLC
Updated on 6 December 2021

Summary

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).

Description

An early feasibility, multi-center, prospective, single-arm, non-randomized study to assess the safety and performance of the CI Percutaneous Ring Annuloplasty System in patients suffering from moderate functional tricuspid regurgitation (FTR). Additional outcomes include short and long-term changes in echocardiographic, functional, and quality of life parameters post-adjustment.

The CI Ring Annuloplasty System is a percutaneous transcatheter repair device delivered by right heart catheterization through the right internal jugular vein. The System is designed to perform annuloplasty using a Ring Delivery System (RDS) to place a complete, flexible ring over the tricuspid annulus on the atrial side of the valve. Fluoroscopy and transesophageal echocardiography are used to guide and monitor the ring placement procedure.

After implantation, the ring becomes embedded within the fibrous tissue of the tricuspid annulus. Approximately 3 months following implantation, the ring is manually adjusted under echocardiographic and fluoroscopic imaging using an Adjustment Tool (AT) until desired reduction of the tricuspid annulus dimension is achieved. Following adjustment, the AT releases a fastener, securing the ring once optimal annular reduction is achieved.

Details
Condition Functional Tricuspid Regurgitation
Treatment CI Percutaneous Ring Annuloplasty System
Clinical Study IdentifierNCT04890821
SponsorCardiac Implants LLC
Last Modified on6 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines
Tricuspid valve annular diameter 40mm or > 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure
Age 18 years old at the time of enrollment
New York Heart Associate Classification II
Symptoms of right heart failure despite optimized medical therapy
Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is a reasonable treatment
Left Ventricular Ejection Fraction (LVEF) 30% within 90 days prior to index implant procedure
The subject has suitable anatomy for investigational device implantation as per imaging requirements
The subject has read and signed the informed consent prior to study related procedures
The subject is willing and able to comply with all required follow-up evaluations and assessments

Exclusion Criteria

Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment
Severe RV dysfunction as assessed by echocardiography
Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.)
Currently participating in another investigational drug or device study
Systolic pulmonary arterial pressure (sPAP) > 70 mmHg as measured by Transthoracic Echocardiography (TTE)
Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure
Tricuspid valve stenosis
Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate
Intra-cardiac thrombus, mass or vegetation requiring active treatment
Prior tricuspid repair or tricuspid replacement
Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated
History of cardiac transplantation
Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE)
Endocarditis or severe infection within 12 months of scheduled implant procedure
Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure
Cerebro-Vascular Accident within the previous 3 months
Hemodynamic instability or on IV inotropes
Contraindication to anticoagulant therapy and dual antiplatelet therapy
Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure
Severe renal impairment or on dialysis
Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (e.g. life expectancy < 1 year), or lead to difficulties for subject compliance with study requirements
Acute anemia
Chronic Oral Steroid Use 6 months
Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
Pulmonary embolism within the last 6 months
Tricuspid Valve Tethering distance > 10 mm
Presence of transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography
Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure
Contra-indicated for blood transfusion or refuses transfusion
Patient undergoing emergency treatment
Patient without appropriate jugular access
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