Transcatheter mitral repair clinical trials
About this trial
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared with Abbott MitraClip in patients with functional mitral regurgitation.1
Functional mitral regurgitation (FMR)
Functional mitral regurgitation (also know as secondary MR) occurs when the mitral valve apparatus is normal, and mitral regurgitation is attributed to a dilated left ventricle which causes papillary muscle displacement, with consequent annular dilatation that prevents the mitral valve leaflets from coapting normally.3
The Edwards PASCAL transcatheter valve repair system
The PASCAL implant
- Central spacer intended to fill the regurgitant orifice area
- Spacer and broad, contoured paddle design reduce stress on leaflets
- Clasps allow for independent leaflet capture and the ability to fine-tune leaflet position
See how it works
Watch the PASCAL repair system procedural animation
CLASP IIF trial design
The CLASP IIF cohort purpose1
The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System + GDMT compared with the MitraClip System + GDMT for the treatment of moderate-to-severe (3+) or severe (4+) FMR in symptomatic heart failure patients.
These patients have been determined by the site’s local multidisciplinary Heart Team to be eligible for transcatheter mitral valve repair.
Both the investigational device group and the control group will receive a minimally invasive treatment, either with the currently approved device or the investigational device.
The CLASP IIF cohort design
Patients will be randomized 1:1 to either treatment with the Edwards PASCAL System + GDMT (Device Group) or MitraClip System + GDMT (Control Group).
Eligibility and enrollment criteria
Key inclusion criteria1
- Patient has 3+ or 4+ mitral regurgitation, as determined by echo
- Patient is determined by the Heart Team to be a candidate for transcatheter mitral valve repair for both PASCAL and MitraClip
- Patient is on stable heart failure medications/Guideline Directed Medical Therapy
Key exclusion criteria1
- Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment, or sufficient reduction in mitral regurgitation
- Patient with refractory heart failure requiring advanced intervention (ie, left ventricular assist device, transplantation, ACC/AHA Stage D heart failure)
- Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
- Other severe valve disorders requiring intervention
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
Patient selection
screening & enrollment
The Heart Team approach for the CLASP IIF cohort
The Heart Team is composed of a multidisciplinary, collaborative group of physicians and caregivers who take a rigorous approach to patient care in this trial to ensure appropriate patient selection.4
Patient screening process
Patient follow up1:
We're here for you
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For details about the trial, visit NCT03706833 at Clinical Trials.gov.
References
- Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial.
- Mitral Valve Regurgitation: Symptoms and Causes. Mayo Clinic: Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/mitral-valve-regurgitation/symptoms-causes/syc-20350178. Accessed May 21, 2020.
- Apostolidou E, Maslow AD, Poppas A. Primary mitral valve regurgitation: Update and review. Glob Cardiol Sci Pract. 2017;2017(1):e201703.
- Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:e57-e185.