Clinical trial NCT02703311: REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
Official title: REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 11
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: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. EF \< 20%
2. LVEDD ≥ 70 mm
3. Heavily calcified annulus or leaflets
4. Significant CAD requiring revascularization
5. Active bacterial endocarditis
6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
7. Renal insufficiency requiring dialysis
8. Life expectancy of less than twelve months
9. Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
10. Pulmonary hypertension ≥ 70mmHg at rest
11. Mitral valve anatomy which may preclude proper device treatment
12. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
13. Severe liver disease
14. Patient is pregnant or lactating
15. Hypersensitivity to Nickel or Chromium
16. Clinically significant bleeding diathesis or coagulopathy
17. History of mitral valve repair
18. TIA or CVA within 3 months

Primary outcomes:
measure: Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
timeFrame: 30 days
Secondary outcomes:
measure: Change in Distance Walked on 6 Minute Walk Test
timeFrame: 6 months over Baseline
measure: Change in Mitral Regurgitation Severity
timeFrame: 6, 12, and 24 months over baseline
Other outcomes:
measure: Change in Distance Walked on 6 Minute Walk Test
timeFrame: 12, and 24 months over baseline
measure: Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 6, 12, and 24 months over baseline
measure: Change in New York Heart Association (NYHA) Class
timeFrame: 6, 12, and 24 months over baseline
measure: Change in Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 6, 12, and 24 months over baseline
measure: Change in Left Ventricular End Systolic Volume (LVESV)
timeFrame: 6, 12, and 24 months over baselines
measure: Number of Participants With Device Success
timeFrame: Discharge
measure: Number of Participants With Patient Success
timeFrame: 6 and 12 months
measure: Number of Days Alive and Out of Hospital
timeFrame: 12 months
measure: Freedom From All-cause Mortality and Major Adverse Events (AE)
timeFrame: 30 days from implant procedure or hospital discharge, whichever is later.
measure: Need for Urgent/Emergent Surgical Intervention
timeFrame: 24 months
Locations:
city: Paris
country: France
facility: Bichat hospital
city: Bad Nauheim
country: Germany
facility: Bad Nauheim, Kerckhoff-Klinik
city: Bonn
country: Germany
facility: Bonn University
city: Giessen
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Halle
country: Germany
facility: University Hospital Halle (Saale)
city: Hamburg
country: Germany
facility: Asklepios Klinik, St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH
city: Koln
country: Germany
facility: Koln, Universitätsklinikum
city: Mainz
country: Germany
facility: Universitatsmedizin Mainz
city: Milano
country: Italy
facility: Hospital san raffaele
Study officials:
References: