Cardioband With Transfemoral Delivery System

Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: Cardioband

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75877
    • Hopital Bichat-Claude Bernard
• Germany
  • Bonn, Germany, 53105
    • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
  • Hamburg, Germany, 20099
    • Asklepios Klinik, St. Georg
  • Köln, Germany, 50937
    • Universitätskliniken zu Köln Klinik III Innere Medizin
  • Mainz, Germany, 55131
    • Zentrum für Kardiologie, Universitätsmedizin Mainz
  • Munich, Germany, 81377
    • Munich University Clinic
• Israel
  • Haifa, Israel, 3109601
    • Rambam Cardiology Research Unit
• Italy
  • Catania, Italy, 95123
    • Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
  • Milano, Italy, 20132
    • San Raffaele University Hospital
• Netherlands
  • Nieuwegein, Netherlands, 3435
    • St.Antonius ziekenhuis
• Switzerland
  • Zurich, Switzerland
    • Universitatsspital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years
• Moderate to severe functional Mitral Regurgitation (MR)
• Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated.
• Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm
• Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site)
• Transseptal catheterization and femoral vein access is determined to be feasible
• Subject is able and willing to give informed consent and follow protocol procedures

Exclusion Criteria:

• Active bacterial endocarditis
• Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
• Heavily calcified annulus or leaflets
• Subjects in whom transesophageal echocardiography is contraindicated
• Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
• CRT implant within 3 months prior to procedure
• Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (>70% by Ultra sound)
• Renal insufficiency requiring dialysis
• Life expectancy of less than twelve months
• Subject is participating in concomitant research studies of investigational products
• Mitral valve anatomy which may preclude proper device treatment
• Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single	Device: Cardioband; Other Names: With Transfemoral delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects	Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance [6MWT]	Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.	Baseline, 6 and 12 months
Performance [MLHFQ]	Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.	Baseline, 6 and 12 months
Performance [Intra-subject Comparison - MR Severity]	All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).	Baseline, discharge, 6 and 12 months
Performance [Full Analysis Data Set - MR Severity]	All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).	Baseline, discharge, 6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce MR [Paired Baseline and Follow-Up]	Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.	Post-adjustment, discharge, and 30 Days
Technical Feasibility of Cardioband Adjustment	The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.	Immediately after procedure
Technical Success Rate of the Implantation of the Cardioband	The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.	Immediately after implantation

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Francesco Maisano, Prof., Universitatsspital Zurich

Publications and helpful links

General Publications

• Maisano F, La Canna G, Latib A, Denti P, Taramasso M, Kuck KH, Colombo A, Alfieri O, Guidotti A, Messika-Zeitoun D, Vahanian A. First-in-man transseptal implantation of a "surgical-like" mitral valve annuloplasty device for functional mitral regurgitation. JACC Cardiovasc Interv. 2014 Nov;7(11):1326-8. doi: 10.1016/j.jcin.2014.08.003. Epub 2014 Oct 15. No abstract available.
• Maisano F, Taramasso M, Nickenig G, Hammerstingl C, Vahanian A, Messika-Zeitoun D, Baldus S, Huntgeburth M, Alfieri O, Colombo A, La Canna G, Agricola E, Zuber M, Tanner FC, Topilsky Y, Kreidel F, Kuck KH. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur Heart J. 2016 Mar 7;37(10):817-25. doi: 10.1093/eurheartj/ehv603. Epub 2015 Nov 18.
• Messika-Zeitoun D, Nickenig G, Latib A, Kuck KH, Baldus S, Schueler R, La Canna G, Agricola E, Kreidel F, Huntgeburth M, Zuber M, Verta P, Grayburn P, Vahanian A, Maisano F. Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. Eur Heart J. 2019 Feb 1;40(5):466-472. doi: 10.1093/eurheartj/ehy424.
• Nickenig G, Hammerstingl C, Schueler R, Topilsky Y, Grayburn PA, Vahanian A, Messika-Zeitoun D, Urena Alcazar M, Baldus S, Volker R, Huntgeburth M, Alfieri O, Latib A, La Canna G, Agricola E, Colombo A, Kuck KH, Kreidel F, Frerker C, Tanner FC, Ben-Yehuda O, Maisano F. Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2039-2047. doi: 10.1016/j.jcin.2016.07.005.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2011
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (ESTIMATE): April 26, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Mitral Valve; Annuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CB1-1/CB1-2