Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

NCT04890821 | Recruiting DMC FDA Device

• 1 other identifier: CLP-100
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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 approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).

Conditions

Tricuspid Regurgitation Functional

Keywords

Tricuspid Valve; Annular Dilatation; Annuloplasty; Tricuspid Valve Repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Safety: Incidence of device or procedure-related major adverse events (MAE)

  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

  30 days post-implant and 30 days post-adjustment

• Technical: Proportion of successful deployment and positioning of the ring implant.

  30 days post-implant and 30 days post-adjustment

• Technical: Freedom from emergency surgery or reintervention

  30 days post-implant and 30 days post-adjustment

• Technical: Rate of Successful Implants

  30 days post-implant

Other Outcomes (2)

• Freedom from Heart Failure Events

  30 days, 90 days, 180 days, and 1-5 years (annually) post-adjustment

• Changes in Heart Failure Biomarkers

  180 days, 1 year, and 2 years post-adjustment

Study Arms (1)

CI Percutaneous Ring Annuloplasty System

EXPERIMENTAL

Patients treated with the CI Percutaneous Ring Annuloplasty System

Device: CI Percutaneous Ring Annuloplasty System

Interventions

CI Percutaneous Ring Annuloplasty System DEVICE

Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.

CI Percutaneous Ring Annuloplasty System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiac Implants LLC: lead

Study Sites (2)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

Study Officials

• Nodar Kipshidze, MPH

  Cardiac Implants LLC

  STUDY DIRECTOR

Central Study Contacts

Nodar Kipshidze, MPH

CONTACT

1-917-370-6247; Nodar@cardiac-implants.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 18, 2021
• Study Start: December 1, 2021
• Primary Completion: August 1, 2022
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)