Status:
RECRUITING
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
Lead Sponsor:
Cardiac Implants LLC
Conditions:
Tricuspid Regurgitation Functional
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 app...
Detailed 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 ≥ mode...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04890821
Start Date
December 1 2021
End Date
September 1 2027
Last Update
November 30 2021
Active Locations (2)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
2
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, United States, 10065