A Study to Evaluate the Safety and Effectiveness of the Edwards PASCAL TrAnScatheter Valve RePair System (CLASP IID/IIF)


About this study

The purpose of this study is to establish the safety and effectiveness of the Edwards PASCAL Transcatheter Mitral Valve Repair System in patients with degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Eighteen (18) years of age or older as of date on informed consent.
  • Patient is able and willing to give informed consent and follow protocol procedures and comply with follow-up visit compliance.
  • Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team.
  • Patient is determined to be a candidate for transcatheter mitral valve repair by a heart team for both the PASCAL System and the MitraClip System; OR patient is determined to be a candidate for the PASCAL System but not the MitraClip System due to valve anatomy (these patients may qualify to participate in the single- arm PASCAL IID registry and will not be part of the randomized cohort).
  • Patient must be deemed a candidate for transseptal catheterization by the site interventional operator.
  • Mitral regurgitation (3+ mo to 4+) by echo (TTE or TEE) as measured by the core lab.
  • Suitable valve and regurgitant jetrphology by TEE.
  • Left ventricular ejection fraction (LVEF) ≥ 20%.
  • LVEDD ≤ 80mm by TTE.

Exclusion Criteria:

  • Primarily degenerative MR.
  • Patient in whom TEE is contraindicated or screening TEE is unsuccessful.
  • Mitral valve anatomy which might limit PASCAL System or MitraClip System access, use, and/or deployment or sufficient reduction in mitral regurgitation will be evaluated on a case-by-case basis by the Central Screening Committee. Anatomic considerations including, but not limited to, the following will be taken into consideration for assignment into the roll-in, randomized, or registry cohorts or excluded altogether:
    • Insufficient mobile leaflet available for grasping the PASCAL or MitraClip System;
    • Evidence of moderate or severe calcification in the grasping area;
    • Presence of a significant cleft or perforation in the grasping area;
    • Lack of both primary and secondary chordal support in the grasping area;
    • Leaflet mobility < 8 mm;
    • Mitral valve orifice area < 4.0 cm^2.
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Chronic scarred thrombi may be considered for inclusion by the core lab.
  • Echocardiographic evidence of severe right ventricular dysfunction.
  • Patient with refractory heart failure requiring advanced intervention (i.e., left ventricular assist device, transplantation) (ACC/AHA Stage D heart failure).
  • Recent stroke.
  • Bradycardia with heart rate < 45 bpm (unless treated with a permanent pacemaker) or uncontrolled tachyarrhythmia.
  • Any recent percutaneous coronary, carotid, endovascular intervention, carotid surgery, or cardiac surgery.
  • Recent implant or revision of any rhythm management device (i.e., pacemaker, ICD, cardiac resynchronization therapy [CRT] with or without cardioverterdefibrillator [CRT-D]).
  • Tricuspid valve disease requiring surgery or severe tricuspid regurgitation.
  • Other severe valve disorders requiring intervention or left ventricular outflow obstruction.
  • Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, or recent myocardial infarction (per WHO definition).
  • Any planned interventional cardiac procedure
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
  • Recent hemodynamic instability (e.g., need for inotropic support or intra-aortic balloon pump or other hemodynamic support device).
  • Known history of untreated severe symptomatic carotid stenosis (> 50% by ultrasound) or asymptomatic carotid stenosis (> 70% by ultrasound).*
  • Severe COPD in which the primary mechanism of dyspnea is pulmonary disease rather than heart failure.
  • Severe aortic stenosis (aortic valve area < 1.0 cm²) or severe aortic regurgitation
  • Absence of CRT with a Class I indication criteria for biventricular pacing.
  • Resting systolic blood pressure 160 mmHg after repeated measurements
  • Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with V wave less than twice the mean of the pulmonary capillary wedge pressure.
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) or DVT/PE in the past 6 months.
  • Presence of an occluded or thrombosed IVC filter that would interfere with the delivery catheter, or presence of an ipsilateral deep vein thrombosis.
  • Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
  • Severe renal insufficiency with eGFR ≤ 25 mL/min or requiring chronic renal replacement therapy.
  • Concurrent medical condition with life expectancy of less than 12 months in the judgment of the investigator.
  • Known bleeding or clotting disorders or patient refuses blood transfusion.
  • Modified Rankin Scale ≥ 4 disability.
  • Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair).
  • Active systemic infection, including active endocarditis.
  • Untreatable hypersensitivity or contraindication to any of the following:
    • Aspirin or Clopidogrel or Ticlopidine; OR
    • Heparin or Bivalirudin; OR
    • Warfarin, Nitinol Alloys (nickel and titanium);
    • Contrast media.
  • 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 procedure and be adherent to an accepted method of contraception.
  • Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment.
  • Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
  • Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship.

* Carotid stenosis refers specifically to the internal carotid artery unless significant external carotid artery involvement is also observed.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mayra Guerrero, M.D.

Open for enrollment

Contact information:

Craig Konwinski C.C.R.C.

(507) 255-8388


More information


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