REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

Cardiovascular Diseases Clinical Trial

— REPAIR  

Official title:

REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02703311
• Other study ID #: CB1-3
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2018

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Bichat hospital	Paris
Germany	Bad Nauheim, Kerckhoff-Klinik	Bad Nauheim
Germany	Bonn University	Bonn
Germany	Universitätsklinikum Gießen und Marburg	Giessen
Germany	University Hospital Halle (Saale)	Halle
Germany	Asklepios Klinik, St. Georg	Hamburg
Germany	Universitäres Herzzentrum Hamburg GmbH	Hamburg
Germany	Koln, Universitätsklinikum	Koln
Germany	Universitatsmedizin Mainz	Mainz
Italy	Hospital san raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Distance Walked on 6 Minute Walk Test	Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline	12, and 24 months over baseline
Other	Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.	6, 12, and 24 months over baseline
Other	Change in New York Heart Association (NYHA) Class	NYHA Class at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baseline
Other	Change in Left Ventricular End Diastolic Volume (LVEDV)	Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baseline
Other	Change in Left Ventricular End Systolic Volume (LVESV)	Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baselines
Other	Number of Participants With Device Success	Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.	Discharge
Other	Number of Participants With Patient Success	Individual patient success (measured at 6 months and 1 year) defined as device success and the following: Discharged from index hospitalization; NYHA class improvement by at least 1 level from baseline	6 and 12 months
Other	Number of Days Alive and Out of Hospital	Days alive and out of hospital due to major cardiovascular events at 1 year	12 months
Other	Freedom From All-cause Mortality and Major Adverse Events (AE)	Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.	30 days from implant procedure or hospital discharge, whichever is later.
Other	Need for Urgent/Emergent Surgical Intervention	Number of patients who undergo urgent/emergent surgical intervention post procedure	24 months
Primary	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	Change in Distance Walked on 6 Minute Walk Test	Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline	6 months over Baseline
Secondary	Change in Mitral Regurgitation Severity	Mitral Regurgitation at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baseline