Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

NCT04100720 | Withdrawn DMC FDA Device

• 1 other identifier: CP 19-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (3)

• 1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant

  Cardiovalve Technical Success defined as: I Successful access, delivery and retrieval of the delivery system; II Successful deployment of correct positioning of the first intended implant; III Freedom from emergency surgery or reintervention related to the device or access procedure without any procedural mortality, stroke, and device dysfunction at 30-day follow-up.

  30 Days

• Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline

  Cardiovalve Clinical Performance will be evaluated as: I The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline; II The reduction in degree of tricuspid regurgitation measured at the time of discharge or 7 days post procedure, whichever comes first, in comparison with baseline Tricuspid Regurgitation is measured using Echocardiography and is graded based on degree of severity using grading conventions from 0 to 4+. 0 = absent 1. = mild 2. = moderate 3. = moderate to severe 4. = severe

  30 Days

• Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days

  The ability of the Cardiovalve to be implanted without Major Device Related Adverse Events through thirty (30) days including: I Death (Cardiovascular mortality vs non-cardiovascular); II Reintervention (operative or transcatheter) due to progressive or recurrent TR or device related complications; III Disabling stroke; IV Myocardial infarction (MVARC definition); V Major access site and vascular complications; VI Fatal or life-threatening bleeding (MVARC Type III-V); VII Arrhythmia and conduction disorder requiring permanent pacing; VIII Right coronary artery occlusion requiring intervention; IX Cardiac tamponade, X Renal failure requiring dialysis

  30 Days

Secondary Outcomes (6)

• Secondary Performance Endpoint - Tricuspid Regurgitation Severity

  30 days, 3 months, 6 months

• Secondary Performance Endpoint - Cusp Insufficiency

  30 days, 3 months, 6 months

• Secondary Performance Endpoint - Unrestricted Movement of Cusps

  30 days, 3 months, 6 months

• Secondary Performance Endpoint - New York Heart Association (NYHA) functional class

  30 days, 3 months, 6 months

• Secondary Performance Endpoint - 6 minute walk test

  30 days, 3 months, 6 months

Study Arms (1)

Cardiovalve Transfemoral Tricuspid Valve

EXPERIMENTAL

Replacement (Implant) delivered through a transfemoral access

Device: Cardiovalve Transfemoral Tricuspid Valve

Interventions

Cardiovalve Transfemoral Tricuspid Valve DEVICE

The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation

Cardiovalve Transfemoral Tricuspid Valve

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is 85 ≥ Age ≥ 18 years
• Participant has severe, symptomatic tricuspid regurgitation (TR) ≥ 3+ based upon echocardiography, as assessed by Independent core laboratory
• Participant is New York Heart Association (NYHA) Class II-IVa
• Participant has left ventricular ejection fraction (LVEF) ≥ 35%
• Participant distance of 6 minute walk test (6MWT) ≥ 60 m
• Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation and Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
• Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System
• Participant approved by the Subject Screening Committee

You may not qualify if:

• Known significant intracardiac shunt (e.g. septal defect) or congenital structural heart disease (PFO's without significant shunts are allowed)
• Significant coronary artery disease requiring treatment
• Primary tricuspid disease (e.g. rheumatic, myxomatous degeneration, tricuspid valve prolapse)
• Severe right ventricular failure per ASE guidelines1
• Systolic pulmonary arterial pressure \> 65 mmHg as assessed by transthoracic echocardiography
• Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
• Cerebrovascular event (stroke, TIA) within the past 3 months
• Active endocarditis or history of mitral/tricuspid endocarditis within the last 12 months
• Patient has significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
• Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count \<90k)
• Documented evidence of significant renal dysfunction (eGFR\<30 ml/min/1.73m2) or on any form of dialysis at time of screening within the last 4 weeks
• Contraindication or known allergy to device's components, to anti-coagulation therapy with vitamin K antagonists or to contrast media that cannot be adequately premedicated
• Patients unsuitable for implantation because of thrombosis of the lower venous system or presence of a vena cava filter
• The patient has contraindication against a transesophageal echo (TEE) during the procedure
• Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)

Sponsors & Collaborators

• Boston Biomedical Associates: lead
• Cardiovalve Ltd.: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (3)

Northwestern University / Bluhm Cardiovascular Institute

Chicago, Illinois, 60611, United States

Location

Columbia University Medical Center / NYPH

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 24, 2019
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)