TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

NCT02981953 | Completed Results

• 1 other identifier: TR1-1
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 8

Brief Summary

The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.

Conditions

Tricuspid Valve Insufficiency; Tricuspid Regurgitation; Tricuspid Valve Regurgitation; Cardiovascular Diseases; Heart Valve Diseases; Heart Diseases; Cardiac Valve Annuloplasty

Keywords

Valtech Cardio; Cardioband; Tricuspid

Outcome Measures

Primary Outcomes (2)

• Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)

  Overall rate of Major Serious Adverse Events (MSAEs)\* and serious adverse device effects (SADE)

  30 days

• Access, Deployment and Positioning of the Cardioband Device

  Successful access, deployment and positioning of the Cardioband device

  Intra-procedure

Secondary Outcomes (26)

• Technical Success

  1, 6, 12, and 24 months

• Tricuspid Regurgitation [Paired Baseline and Follow-Up]

  1, 6, 12, and 24 months over baseline

• Tricuspid Regurgitation [Full Analysis Data Set]

  1, 6, 12, and 24 months over baseline

• Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]

  1, 6, 12, and 24 months over baseline

• Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]

  1, 6, 12, and 24 months over baseline

Study Arms (1)

Cardioband Tricuspid procedure

OTHER

Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance

Device: Cardioband Tricuspid

Interventions

Cardioband Tricuspid DEVICE

The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.

Cardioband Tricuspid procedure

Eligibility Criteria

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

You may qualify if:

• Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg
• ≥18 years old
• New York Heart Association (NYHA) Class II-IVa
• Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
• LVEF ≥ 30%
• Patient is willing and able to comply with all specified study evaluations
• The Local Site Heart Team concur that surgery will not be offered as a treatment option
• Transfemoral access of the Cardioband is determined to be feasible

You may not qualify if:

• Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
• Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
• Previous tricuspid valve repair or replacement
• Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
• Active endocarditis
• MI or known unstable angina within the 30 days prior to the index procedure
• Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index
• Hemodynamic instability or on IV inotropes
• Cerebrovascular Accident (CVA) within the past 6 months
• Subject is on chronic dialysis
• Anemia (Hb \< 9 g/dL) not corrected by transfusion
• Bleeding disorders or hypercoaguable state
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Contraindication to anticoagulants
• Known allergy to stainless steel, nickel, and/or polyester

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (8)

Hôpital Bichat-Claude Bernard

Paris, 18 75877, France

Location

Bonn University - Universitätsklinikum Bonn

Bonn, Germany

Location

Universitätsklinikum Köln

Cologne, Germany

Location

Asklepios Klinik, St. Georg

Hamburg, 5 20099, Germany

Location

Universitätsklinik Hamburg Eppendorf, Herzzentrum

Hamburg, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Location

LMU Klinikum der Universität München, Medizinische Klinik I

Munich, Germany

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (2)

• Nickenig G, Weber M, Schuler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, Maisano F. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.

  PMID: 33046437 DERIVED

• Nickenig G, Weber M, Schueler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Kuck KH, Kreidel F, Juliard JM, Brochet E, Latib A, Agricola E, Baldus S, Friedrichs K, Vandrangi P, Verta P, Hahn RT, Maisano F. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.

  PMID: 30999993 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Cardiovascular Diseases; Heart Valve Diseases; Heart Diseases

Results Point of Contact

• Title: Ted Feldman
• Organization: Edwards Lifesciences

Feldman_Info@edwards.com

949-250-2500

Study Officials

• Georg Nickenig, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 20, 2016
• First Posted: December 5, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: November 12, 2019
• Last Updated: June 28, 2021
• Results First Posted: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); IT (1); DE (6)