Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Cardiac Implants LLC
Study ID
NCT04890821
Status
Recruiting
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Conditions

  • Tricuspid Regurgitation Functional

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CI Percutaneous Ring Annuloplasty System — DEVICE
    Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.

Study Details

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).

Key Dates

Start date
Dec 31, 2021
Status verified
Nov 2021
Primary completion
Aug 31, 2022
Completion
Sep 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CI Percutaneous Ring Annuloplasty System
    Patients treated with the CI Percutaneous Ring Annuloplasty System

Primary Outcome Measure

Freedom from device or procedure-related mortality [ Time Frame: 30 days post-adjustment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hackensack University Medical CenterHackensackNew Jersey07601
Peter Canino
[email protected]
551-996-3775
Tilak Pasala, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine-New York Presbyterian HospitalNew YorkNew York10065
Dolores Reynolds
[email protected]
212-746-4617
Mark Reisman, MD (PRINCIPAL_INVESTIGATOR)

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Hackensack University Medical Center· Hackensack, NJWeill Cornell Medicine-New York Presbyterian Hospital· New York, NY

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