NCT01841554

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
6 countries

11 active sites

Status
completed

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 Start

First participant enrolled

September 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 11, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

4.9 years

First QC Date

April 23, 2013

Results QC Date

October 23, 2019

Last Update Submit

November 26, 2020

Conditions

Mitral Regurgitation

Keywords

Mitral ValveAnnuloplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Performance [6MWT]

    Baseline, 6 and 12 months

  • Performance [MLHFQ]

    Baseline, 6 and 12 months

  • Performance [Intra-subject Comparison - MR Severity]

    Baseline, discharge, 6 and 12 months

  • Performance [Full Analysis Data Set - MR Severity]

    Baseline, discharge, 6 and 12 months

Other Outcomes (3)

  • Reduce MR [Paired Baseline and Follow-Up]

    Post-adjustment, discharge, and 30 Days

  • Technical Feasibility of Cardioband Adjustment

    Immediately after procedure

  • Technical Success Rate of the Implantation of the Cardioband

    Immediately after implantation

Study Arms (1)

Single

EXPERIMENTAL
Device: Cardioband

Interventions

CardiobandDEVICE
Also known as: With Transfemoral delivery system
Single

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Bichat-Claude Bernard

Paris, 75877, France

Location

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II

Bonn, 53105, Germany

Location

Universitätskliniken zu Köln Klinik III Innere Medizin

Cologne, 50937, Germany

Location

Asklepios Klinik, St. Georg

Hamburg, 20099, Germany

Location

Zentrum für Kardiologie, Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Munich University Clinic

Munich, 81377, Germany

Location

Rambam Cardiology Research Unit

Haifa, 3109601, Israel

Location

Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

Catania, 95123, Italy

Location

San Raffaele University Hospital

Milan, 20132, Italy

Location

St.Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 25326746BACKGROUND

  • 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.

    PMID: 26586779BACKGROUND

  • 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.

    PMID: 30124798DERIVED

  • 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.

    PMID: 27712741DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Ted Feldman
Organization
Edwards Lifesciences
Feldman_Info@edwards.com
949-250-2500

Study Officials

  • Francesco Maisano, Prof.

    Universitätsspital Zürich

    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

April 23, 2013

First Posted

April 26, 2013

Study Start

September 1, 2011

Primary Completion

August 1, 2016

Study Completion

June 1, 2018

Last Updated

November 30, 2020

Results First Posted

March 11, 2020

Record last verified: 2020-11

Locations

FR(1)DE(5)IT(2)CH(1)IL(1)NL(1)