NCT05486832

Brief Summary

The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
92mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Dec 2022Dec 2033

First Submitted

Initial submission to the registry

August 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2033

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

3.7 years

First QC Date

August 2, 2022

Last Update Submit

December 31, 2025

Conditions

Tricuspid Regurgitation

Keywords

Tricuspid valveHeart valveCardiovascular disease

Outcome Measures

Primary Outcomes (2)

  • Freedom from device or procedure-related adverse events

    Freedom from device or procedure-related adverse events

    30 days

  • Reduction in TR grade

    Reduction in TR in comparison to baseline

    30 days

Secondary Outcomes (2)

  • Six minute walk test

    30 days, 6 months, 12 months, annual for five years

  • KCCQ

    30 days, 6 months, 12 months, annual for five years

Study Arms (1)

Cardiovalve TR replacement Group

EXPERIMENTAL

Cardiovalve TR valve replacement System

Device: Cardiovalve TR valve replacement System

Interventions

Cardiovalve TR valve replacement SystemDEVICE

The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.

Cardiovalve TR replacement Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Functional TR ≥3+
  • Symptomatic, NYHA Class II-IVa
  • Patient approved by the Subject Screening Committee

You may not qualify if:

  • Cardiac anatomy deemed not suitable for the Cardiovalve TR system
  • Hemodynamic instability
  • Severe right ventricular failure
  • Refractory heart failure requiring advanced intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Universität Bochum

Bad Oeynhausen, 32545, Germany

RECRUITING

Charité university

Berlin, 10117, Germany

RECRUITING

Uniklinik Bonn

Bonn, 53127, Germany

RECRUITING

Herzzentrum Uniklinik

Cologne, 50937, Germany

RECRUITING

Universitäres Herz

Hamburg, 20251, Germany

RECRUITING

University Heart Center Lübeck

Lübeck, 20251, Germany

RECRUITING

Universitätsklinikum - Regensburg

Regensburg, 93053, Germany

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart Diseases

Study Officials

  • Georg Nickenig, Dr

    Bonn Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Raveh Arbel

CONTACT

+972528591891danar@cardiovalve.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective, single arm, open label, multi center
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 4, 2022

Study Start

December 9, 2022

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

December 15, 2033

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

DE(7)