REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

NCT02703311 | Terminated Results

• 1 other identifier: CB1-3
• Study Type: interventional
• Target: 11
• Locations: 3 countries
• Sites: 10

Brief Summary

The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR. Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.

Conditions

Mitral Valve Insufficiency; Cardiac Valve Annuloplasty; Mitral Valve Annuloplasty; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Regurgitation

Keywords

Valtech Cardio; Cardioband; Mitral Valve

Outcome Measures

Primary Outcomes (1)

• Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.

  Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline

  30 days

Secondary Outcomes (2)

• Change in Distance Walked on 6 Minute Walk Test

  6 months over Baseline

• Change in Mitral Regurgitation Severity

  6, 12, and 24 months over baseline

Other Outcomes (10)

• Change in Distance Walked on 6 Minute Walk Test

  12, and 24 months over baseline

• Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  6, 12, and 24 months over baseline

• Change in New York Heart Association (NYHA) Class

  6, 12, and 24 months over baseline

Study Arms (1)

Cardioband procedure

OTHER

Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance

Device: Cardioband

Interventions

Cardioband DEVICE

Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance

Cardioband procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Severe (3+ to 4+) secondary Mitral Regurgitation
• Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
• The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
• Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
• Subject is willing and able to provide informed consent and follow protocol

You may not qualify if:

• EF \< 20%
• LVEDD ≥ 70 mm
• Heavily calcified annulus or leaflets
• Significant CAD requiring revascularization
• Active bacterial endocarditis
• Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
• Renal insufficiency requiring dialysis
• Life expectancy of less than twelve months
• Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
• Pulmonary hypertension ≥ 70mmHg at rest
• Mitral valve anatomy which may preclude proper device treatment
• Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
• Severe liver disease
• Patient is pregnant or lactating
• Hypersensitivity to Nickel or Chromium

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (10)

Bichat hospital

Paris, 18 75877, France

Location

Bad Nauheim, Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Bonn University

Bonn, Germany

Location

Koln, Universitätsklinikum

Cologne, Germany

Location

Universitätsklinikum Gießen und Marburg

Giessen, Germany

Location

University Hospital Halle (Saale)

Halle, Germany

Location

Asklepios Klinik, St. Georg

Hamburg, 5 20099, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, Germany

Location

Universitatsmedizin Mainz

Mainz, Germany

Location

Hospital san raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases

Results Point of Contact

• Title: Ted Feldman
• Organization: Edwards Lifesciences

Feldman_Info@edwards.com

949-250-2500

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: February 22, 2016
• First Posted: March 9, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 9, 2020
• Results First Posted: November 9, 2020

Record last verified: 2020-10

Locations

IT (1); DE (8); FR (1)