NCT03779490

Brief Summary

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
3 countries

14 active sites

Status
active not 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 Progress80%
Jul 2019Dec 2027

First Submitted

Initial submission to the registry

December 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 24, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

December 15, 2018

Last Update Submit

April 4, 2023

Conditions

Tricuspid RegurgitationTricuspid Insufficiency

Keywords

Edwards Cardioband TRAnnuloplastyTricuspid RepairTricuspid Valve

Outcome Measures

Primary Outcomes (1)

  • Procedure Success

    Reduction in severity of Tricuspid Regurgitation at discharge.

    Hospital discharge, 2-7 days post-procedure

Secondary Outcomes (4)

  • Major Adverse Event Rate

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Procedure Success

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Change in Quality of Life - KCCQ

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Change in Quality of Life - EQ-5D-5L

    30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Interventions

Transcatheter Tricuspid Valve RepairDEVICE

Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Symptomatic patients with chronic functional tricuspid regurgitation (FTR)

You may qualify if:

  • Eighteen (18) years of age or older
  • Moderate or greater functional Tricuspid Regurgitation (TR)
  • Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use.

You may not qualify if:

  • Patients deemed anatomically unsuitable for the device by echocardiography
  • Patients in whom transesophageal echocardiography (TEE) is contraindicated
  • Previous tricuspid valve repair or replacement
  • Severe aortic, mitral and / or pulmonic valve stenosis
  • Severe aortic, mitral and / or pulmonic valve regurgitation
  • Renal Insufficiency requiring dialysis or severe kidney renal disease
  • Life expectancy of less than twelve months
  • Patient is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ulm University

Ulm, Bavaria, 89081, Germany

Location

Universitätsklinik der Ruhr-Universität Bochum

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Herzzentrum der UniKlinik Köln

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Charité - Universitätsmedizin Campus Mitte

Berlin, 10117, Germany

Location

Berlin Charité-Benjamin Franklin

Berlin, 12203, Germany

Location

Universitätsklinikum Bonn

Bonn, 51312, Germany

Location

Herzzentrum Universitätsklinik Dresden

Dresden, 01307, Germany

Location

University Hospital Erlangen

Erlangen, 91054, Germany

Location

Universitätsmedizin Göttingen, Herzzentrum Göttingen

Göttingen, 37075, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

UKE Hamburg

Hamburg, 20246, Germany

Location

Katholisches Marienkrankenhaus

Hamburg, 22087, Germany

Location

Hospital Universitario Ramón y Cahal

Madrid, 28034, Spain

Location

Universitätsspital Bern (Inselspital)

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13.

    PMID: 35576863DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Georg Nickenig, MD

    Universitätsklinikum Bonn, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 19, 2018

Study Start

July 24, 2019

Primary Completion

September 30, 2022

Study Completion (Estimated)

December 31, 2027

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(12)CH(1)ES(1)