Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

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).

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation Functional
• Intervention / Treatment: Device: CI Percutaneous Ring Annuloplasty System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Not yet recruiting
      • Hackensack University Medical Center
      • Contact: Peter Canino; Phone Number: 551-996-3775; Email: Peter.Canino@hmhn.org
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine-New York Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 index implant procedure.
3. Age ≥ 18 years old at the time of enrollment.
4. New York Heart Associate Classification ≥ II.
5. Symptoms of right heart failure despite optimized medical therapy.
6. 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.
7. Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure
8. The subject has suitable anatomy for investigational device implantation as per imaging requirements.
9. The subject has read and signed the informed consent prior to study related procedures.
10. The subject is willing and able to comply with all required follow-up evaluations and assessments.

Exclusion Criteria:

1. Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
2. Severe RV dysfunction as assessed by echocardiography.
3. Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
4. Currently participating in another investigational drug or device study.
5. Systolic pulmonary arterial pressure (sPAP) > 70 mmHg as measured by Transthoracic Echocardiography (TTE).
6. 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.
7. Tricuspid valve stenosis.
8. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate.
9. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
10. Prior tricuspid repair or tricuspid replacement.
11. Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated.
12. History of cardiac transplantation.
13. Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE).
14. Endocarditis or severe infection within 12 months of scheduled implant procedure.
15. Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure.
16. Cerebro-Vascular Accident within the previous 3 months.
17. Hemodynamic instability or on IV inotropes.
18. Contraindication to anticoagulant therapy and dual antiplatelet therapy.
19. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure.
20. Severe renal impairment or on dialysis.
21. 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.
22. Acute anemia.
23. Chronic Oral Steroid Use ≥ 6 months.
24. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
25. Pulmonary embolism within the last 6 months.
26. Tricuspid Valve Tethering distance > 10 mm.
27. Presence of transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
28. Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure.
29. Contra-indicated for blood transfusion or refuses transfusion.
30. Patient undergoing emergency treatment.
31. Patient without appropriate jugular access.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CI Percutaneous Ring Annuloplasty System; Patients treated with the CI Percutaneous Ring Annuloplasty System	Device: CI Percutaneous Ring Annuloplasty System; Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 days post-adjustment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	30 days post-implant and 30 days post-adjustment
Technical: Rate of Successful Implants	The proportion of subjects with successful ring implants.	30 days post-implant
Technical: Proportion of Successful Procedures	Proportion of successful procedures, as defined in Mitral Valve Academic Research Consortium (MVARC)	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	1 year post-adjustment
Functional: Changes in Distance Walked for Exercise Tolerance	Changes in distance walked, assessed by 6 Minute Walk Test	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)	1 year post-adjustment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Heart Failure Events	Freedom from heart failure events post-adjustment defined as a heart failure hospitalization, stratified by cardiac related vs. non-cardiac events compared to baseline.	30 days, 90 days, 180 days, and 1-5 years (annually) post-adjustment
Changes in Heart Failure Biomarkers	Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP) levels as compared to baseline.	180 days, 1 year, and 2 years post-adjustment

Collaborators and Investigators

• Sponsor: Cardiac Implants LLC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): September 1, 2027

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (ACTUAL): May 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Annuloplasty; Tricuspid Valve Repair; Tricuspid Valve; Annular Dilatation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CLP-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes