Trial Search Results

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Intervention(s):

  • Device: Edwards PASCAL System
  • Device: Abbott Mitraclip System

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Eighteen (18) years of age or older

   - Patient is able and willing to give informed consent and follow protocol procedures,
   and comply with follow‐up visit requirements.

   - Patient is determined to be at prohibitive risk for mitral valve surgery by the heart
   team (CLASP IID cohort only).

   - Patient is on stable heart failure medications/Guideline Directed Medical Therapy
   (CLASP IIF cohort only)

   - Patient is determined to be a candidate for transcatheter mitral valve repair by the
   heart team for both PASCAL and MitraClip

   - Mitral regurgitation (3+ to 4+) by echo

   - Suitable valve and regurgitant jet morphology

   - Elevated BNP > 150 pg/ml or corrected NT-pro BNP of > 600 pg/ml or heart failure
   hospitalization within the past 12 months (CLASP IIF cohort only)

Exclusion Criteria:

   - Patient in whom a TEE is contraindicated or screening TEE is unsuccessful

   - 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 (i.e.
   biventricular pacemakers, left ventricular assist device, transplantation) (ACC/AHA
   Stage D heart failure)

   - Clinically significant, untreated coronary artery disease

   - Recent stroke

   - 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

   - Any prior mitral valve surgery (except surgical annuloplasty) or transcatheter mitral
   valve procedure

   - Active rheumatic heart disease or rheumatic etiology for MR

   - Severe aortic stenosis or regurgitation

   - Known history of severe symptomatic carotid stenosis

   - History of deep vein thrombosis (DVT) or pulmonary embolism (PE)

   - Severe COPD

   - Pregnant or planning pregnancy within next 12 months. Note: Female patients of
   childbearing potential need to have a negative pregnancy test performed within 14 days
   prior to intervention and be adherent to an accepted method of contraception

   - Concurrent medical condition with a life expectancy of less than 12 months in the
   judgment of the Investigator

   - Patient is currently participating in another investigational biologic, drug or device
   clinical study where the primary study endpoint was not reached at time of enrollment

   - Other medical, social, or psychological conditions that preclude appropriate consent
   and follow-up, including patients under guardianship

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting