Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Launched by EDWARDS LIFESCIENCES · Oct 12, 2018

Keywords

ClinConnect Summary

The Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial is researching a new treatment option for patients with degenerative mitral regurgitation, a condition where the heart's mitral valve doesn’t close properly, causing blood to flow backward. This trial is specifically looking at the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in individuals who are considered too high-risk for traditional heart surgery. The study includes patients who are at least 18 years old and have been evaluated by a heart team. To qualify, patients should have significant mitral regurgitation and may be on specific heart medications.

If you decide to participate, you will undergo evaluations to ensure this treatment is appropriate for you. This trial is currently recruiting participants of all genders, typically between the ages of 65 and 74. Throughout the study, participants will be closely monitored to assess their health and the procedure's effectiveness. It’s important to note that certain medical conditions or prior heart surgeries may prevent eligibility, so a thorough screening will take place. This trial aims to provide new hope for patients who have limited treatment options due to their health risks.

Gender

ALL

Eligibility criteria

• 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 corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
• • LVEF ≥ 20% (and ≤ 50%; 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. left ventricular assist device, Status ≤5 heart 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 or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
• • Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
• • Active rheumatic heart disease or rheumatic etiology for MR
• • Severe aortic stenosis or regurgitation
• • Known history of untreated, severe carotid stenosis
• • Recent 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