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Cardioband With Transfemoral Delivery System

NCT ID: NCT01841554

Last Updated: 2020-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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Conditions

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Mitral Regurgitation

Keywords

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Mitral Valve Annuloplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single

Group Type EXPERIMENTAL

Cardioband

Intervention Type DEVICE

Interventions

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Cardioband

Intervention Type DEVICE

Other Intervention Names

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With Transfemoral delivery system

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Maisano, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Zürich

Locations

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Hôpital Bichat-Claude Bernard

Paris, , France

Site Status

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II

Bonn, , Germany

Site Status

Universitätskliniken zu Köln Klinik III Innere Medizin

Cologne, , Germany

Site Status

Asklepios Klinik, St. Georg

Hamburg, , Germany

Site Status

Zentrum für Kardiologie, Universitätsmedizin Mainz

Mainz, , Germany

Site Status

Munich University Clinic

Munich, , Germany

Site Status

Rambam Cardiology Research Unit

Haifa, , Israel

Site Status

Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

Catania, , Italy

Site Status

San Raffaele University Hospital

Milan, , Italy

Site Status

St.Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

Countries

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France Germany Israel Italy Netherlands Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 25326746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26586779 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30124798 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27712741 (View on PubMed)

Other Identifiers

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CB1-1/CB1-2

Identifier Type: -

Identifier Source: org_study_id

NCT01533883

Identifier Type: -

Identifier Source: nct_alias