CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Corvivo Cardiovascular, Inc.
Study ID
NCT05742906
Status
Recruiting
Apply to this trial

Conditions

  • Tricuspid Valve Disease
  • Tricuspid Valve Insufficiency

Eligibility Criteria

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

Interventions

  • Tricuspid valve replacement with the Cor TRICUSPID ECM Valve — DEVICE
    Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.

Study Details

The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are: * whether the device may be implanted successfully and safely, and * whether the device effectively treats tricuspid valve disease and dysfunction through 12 months Participants will undergo: * preoperative evaluation * tricuspid valve replacement with the Cor TRICUSPID ECM Valve * postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years

Key Dates

Start date
Aug 10, 2022
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM Valve
    Adults (\>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve
  • Other: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve
    Pediatrics (\<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve
  • Other: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve
    Adults (\>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve
  • Other: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve
    Pediatrics (\<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve

Primary Outcome Measure

Safety Outcome - Procedural Success [ Time Frame: 30 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
St Francis HospitalIndianapolisIndiana46237
Marc Gerdisch, MD
[email protected]
(317) 851-2331
Marc Gerdisch, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical Center/New York PresbyterianNew YorkNew York10032
Emile Bacha, MD
[email protected]
1-212-305-2688

Find similar trials in Indianapolis, IN

By research site
St Francis Hospital· Indianapolis, INColumbia University Irving Medical Center/New York Presbyterian· New York, NY

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