Transcatheter Repair of Mitral Regurgitation with Cardioband System Post Market Study (MiBAND): A European prospective, multicenter study to assess transcatheter mitral valve repair with Edwards Cardioband System in patients with symptomatic mitral regurgitation.

Phase 4

Withdrawn

• Conditions: mitral insufficiency; Mitral valve regurgitation; 10019280

• Registration Number: NL-OMON49230
• Lead Sponsor: Edwards Lifesciences, LCC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Age * 18 years
2. MR (* 2+ by echocardiography * refer to Appendix C)
3. NYHA Class II-III-ambulatory IV heart failure symptoms despite guideline
directed medical therapy (GDMT), including Cardiac Resynchronization Therapy
(CRT) if indicated
4. LVEF >20% and LVEDD * 80mm by echocardiography;
5. Patient is eligible to receive the Edwards Cardioband Mitral System per the
current approved indications for use.
6. Patient is willing and able to attend all follow-up visits and perform all
tests.

Exclusion Criteria

1. Active bacterial endocarditis
2. Severe organic lesions with retracted chordae or congenital malformations
with lack of valvular tissue
3. Heavily calcified annulus or leaflets
4. Patients in whom transesophageal echocardiography is contraindicated
5. Untreatable hypersensitivity or contraindication to any of the following:
Anticoagulation/antiplatelet regimen
Nitinol alloys (Nickel and Titanium)
Contrast media
6. Any carotid intervention or carotid surgery within 30 days
7. Any cardiac surgery or major endovascular surgery within 3 months
8. Pre-existing prosthetic heart valve or annuloplasty in the mitral position
9. Severe right ventricular (RV) dysfunction (e.g. Pulmonary hypertension
[PHTN] * 70 mmHg at rest)
10. Renal insufficiency requiring dialysis or severe kidney renal disease with
eGFR * 30 mL/min/1.73 m2
11. Severe COPD, defined as has recurrent (> 2 per 12 months) hospitalizations
for COPD exacerbation, or continuous use of home oxygen
12. End-stage Heart Failure with inotrope support and/or consideration for LVAD
or heart transplant
13. Concurrent medical condition with a life expectancy of less than 12 months
in the judgment of the Investigator
14. Patient is pregnant or lactating
15. Any patient considered to be part of a vulnerable population (as defined in
section 12.1)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reduction in severity of MR at discharge (core lab assessment)</p><br>