Cardioband With Transfemoral Delivery System

Mitral Regurgitation Clinical Trial

Official title:

Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841554
• Other study ID #: CB1-1/CB1-2
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: June 2018

Study information

• Verified date: November 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01533883

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Cardioband

Locations

Country	Name	City	State
France	Hôpital Bichat-Claude Bernard	Paris
Germany	Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II	Bonn
Germany	Asklepios Klinik, St. Georg	Hamburg
Germany	Universitätskliniken zu Köln Klinik III Innere Medizin	Köln
Germany	Zentrum für Kardiologie, Universitätsmedizin Mainz	Mainz
Germany	Munich University Clinic	Munich
Israel	Rambam Cardiology Research Unit	Haifa
Italy	Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"	Catania
Italy	San Raffaele University Hospital	Milano
Netherlands	St.Antonius Ziekenhuis	Nieuwegein
Switzerland	UniversitätsSpital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

France,  Germany,  Israel,  Italy,  Netherlands,  Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	Performance [6MWT]	Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.	Baseline, 6 and 12 months
Secondary	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
Secondary	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
Secondary	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