The objectives of the study are to describe:1. The efficacy of the Edwards Cardioband Mitral System in improving mitral regurgitation, functional status, and quality of life.2. The safety of the Edwards Cardioband Mitral System.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction in severity of MR at discharge (core lab assessment)
Secondary outcome
* MR severity assessed by echocardiography (core lab assessment) at 30 days, 6
months, 1 year and annually thereafter until 3 years post implant
* 6MWD assessed at 30 days, 6 months, 1 year and annually thereafter until 3
years post implant
* Quality of life as assessed by the EQ-5D-5L and KCCQ at 30 days, 6 months, 1
year and annually thereafter until 3 years post implant
* NYHA Class at 30 days, 6 months, 1 year and annually thereafter until 3 years
post implant
* Device success: Device is deployed as intended and the delivery system is
successfully retrieved as intended at the time of the patient*s exit from the
cardiac catheterization laboratory (per device analysis)
* Procedural Success:
o For patients with baseline MR grade equal to 2+: device success with evidence
of MR * 1+ at discharge and without the need for a surgical or percutaneous
intervention prior to hospital discharge (per patient analysis).
o For patients with baseline MR grade > 2+: device success with evidence of MR
* 2+ at discharge and without the need for a surgical or percutaneous
intervention prior to hospital discharge (per patient analysis).
* Clinical Success:
o For patients with baseline MR grade equal to 2+: procedural success with
evidence of MR * 1+ at discharge and without MAEs at 30 days (per patient
analysis).
o For patients with baseline MR grade > 2+: procedural success with evidence of
MR * 2+ at discharge without MAEs at 30 days (per patient analysis).
Background summary
The Cardioband Mitral Reconstruction System is indicated for the repair and/or
remodeling of pathological mitral valves.
Study objective
The objectives of the study are to describe:
1. The efficacy of the Edwards Cardioband Mitral System in improving mitral
regurgitation, functional status, and quality of life.
2. The safety of the Edwards Cardioband Mitral System.
Study design
Multi-center single arm prospective study. Patients will be followed for up to
3 years. Interim analysis will be performed after enrollment of 100 patients.
Intervention
mitral valve repair with Edwards Cardioband System
Study burden and risks
No additional risks to study participation. Participation involves time
commitment in terms of consent procedure, answering questions, completion of
questionnaires and 6 minute walking test at follow ups.
One Edwards Way NA
Irvine CA 92614
US
One Edwards Way NA
Irvine CA 92614
US
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03600688 |
| CCMO | NL71033.058.19 |