Tricuspid Regurgitation FunctionalNCT04890821
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
A study testing CI Percutaneous Ring Annuloplasty System in people with Tricuspid Regurgitation Functional, run by Cardiac Implants LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation Functional
- What is being tested?
- CI Percutaneous Ring Annuloplasty System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2021to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Peter Canino, 551-996-3775, Peter.Canino@hmhn.org
Tilak Pasala, MD
- Recruiting
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065
Dolores Reynolds, 212-746-4617, Dtr2001@med.cornell.edu
Mark Reisman, MD
About this study
Official title: Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation
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).
Read the 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 ≥ 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.
- Conditions
- Tricuspid Regurgitation Functional
- Being tested
- CI Percutaneous Ring Annuloplasty System
- Keywords
- Tricuspid Valve, Annular Dilatation, Annuloplasty, Tricuspid Valve Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI Percutaneous Ring Annuloplasty SystemDevice
Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.
| Study group | Role | What they receive |
|---|---|---|
| CI Percutaneous Ring Annuloplasty System | Experimental | Patients treated with the CI Percutaneous Ring Annuloplasty System Receives: Device: CI Percutaneous Ring Annuloplasty System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device or procedure-related mortality
Freedom from mortality determined to be primarily caused by the device or procedure in the primary endpoint cohort. Events adjudicated by a Clinical Events Committee (CEC).
Measured: 30 days post-adjustment
Secondary outcomes (23)
Safety: Incidence of device or procedure-related major adverse events (MAE)
The incidence of MAEs determined to be primarily caused by the device or procedure. Events adjudicated by CEC.
Measured: 30, 60, and 90 days post-implant; 30 days, 3 months, 6 months, 12 months, and 2-5 years (annually) post-adjustment
Technical: Proportion of successful access, delivery, and retrieval device delivery system
The proportion of successful access, delivery, and retrieval of the device delivery system.
Measured: 30 days post-implant and 30 days post-adjustment
Technical: Proportion of successful deployment and positioning of the ring implant.
The proportion of successful deployment and correct/stable positioning of the ring implant.
Measured: 30 days post-implant and 30 days post-adjustment
Technical: Freedom from emergency surgery or reintervention
The proportion of subjects free from emergency surgery or reintervention casually related to the device or access procedure.
Measured: 30 days post-implant and 30 days post-adjustment
Technical: Rate of Successful Implants
The proportion of subjects with successful ring implants.
Measured: 30 days post-implant
Technical: Proportion of Successful Procedures
Proportion of successful procedures, as defined in Mitral Valve Academic Research Consortium (MVARC)
Measured: 30 days post-implant and 30 days post-adjustment
Technical: Number of device stakes embedded in tissue
Proportion of device stakes embedded in tissue vs. stakes remain embedded at follow-up, per subject, as assessed through multi-modality imaging (i.e. fluoroscopy, cine, TEE, and Cardiac CT) and evaluated by an independent Core Lab(s).
Measured: 30 days post-implant, 30 days post-adjustment, and 1 year post-adjustment
Mechanistic: Changes in TR Severity
The changes in TR severity, characterized per the American Society of Echocardiography (ASE) guidelines, as compared to baseline, to be evaluated by independent Core Lab.
Measured: 30 and 90 days post-implant; and 30, 90, 180, and 1-2 years (annually) post-adjustment
Mechanistic: Echocardiographic changes: Changes Tricuspid Valve (TV) Annular Diameter
Changes in TV annular diameter as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in TV Area
Changes in TV area as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Vena Contracta (VC) dimensions
Changes in VC dimensions as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Proximal isovelocity surface area (PISA) effective regurgitant orifice area (EROA)
Changes in PISA EROA as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Quantitive EROA
Changes in quantitative EROA as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in TV Regurgitant Volume
Changes in TV regurgitant volume as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Right Atrium (RA) Dimensions
Changes in RA dimensions as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Right Ventricle (RV) Dimensions
Changes in RV dimensions (cm) as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Inferior Vena Cava (IVC) Dimensions
Changes in IVC dimensions as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Changes in TAPSE as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Left Atrium (LA) Dimensions
Changes in LA dimensions as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Mechanistic: Echocardiographic changes: Changes in Left Ventricle (LV) Dimensions
Changes in LV dimensions as compared to baseline, determined via echocardiography.
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
Functional: Changes in NYHA Classification
Changes in New York Heart Association (NYHA) classification as compared to baseline.
Measured: 1 year post-adjustment
Functional: Changes in Distance Walked for Exercise Tolerance
Changes in distance walked, assessed by 6 Minute Walk Test
Measured: 1 year post-adjustment
Functional: Changes in Quality of Life Scores and Sub-Domains
Changes in quality of life overall score and sub-domains in comparison to baseline values as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: 1 year post-adjustment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study startDec 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiac Implants LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nodar Kipshidze, MPH, Study director, Cardiac Implants LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890821
- Sponsor's protocol ID
- CLP-100
- Status last verified
- Nov 2021
- First submitted
- 7 May 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No