Clinical trial NCT01841554: Cardioband With Transfemoral Delivery System
Official title: Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Regurgitation
Keywords: Mitral Valve
Annuloplasty
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
timeFrame: 30 days
Secondary outcomes:
measure: Performance [6MWT]
timeFrame: Baseline, 6 and 12 months
measure: Performance [MLHFQ]
timeFrame: Baseline, 6 and 12 months
measure: Performance [Intra-subject Comparison - MR Severity]
timeFrame: Baseline, discharge, 6 and 12 months
measure: Performance [Full Analysis Data Set - MR Severity]
timeFrame: Baseline, discharge, 6 and 12 months
Other outcomes:
measure: Reduce MR [Paired Baseline and Follow-Up]
timeFrame: Post-adjustment, discharge, and 30 Days
measure: Technical Feasibility of Cardioband Adjustment
timeFrame: Immediately after procedure
measure: Technical Success Rate of the Implantation of the Cardioband
timeFrame: Immediately after implantation
Locations:
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
city: Hamburg
country: Germany
facility: Asklepios Klinik, St. Georg
city: Köln
country: Germany
facility: Universitätskliniken zu Köln Klinik III Innere Medizin
city: Mainz
country: Germany
facility: Zentrum für Kardiologie, Universitätsmedizin Mainz
city: Munich
country: Germany
facility: Munich University Clinic
city: Haifa
country: Israel
facility: Rambam Cardiology Research Unit
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
city: Milano
country: Italy
facility: San Raffaele University Hospital
city: Nieuwegein
country: Netherlands
facility: St.Antonius Ziekenhuis
city: Zurich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: Universitätsspital Zürich
name: Francesco Maisano, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.