Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): 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 to Abbott MitraClip in Patients With Mitral Regurgitation
Edwards PASCAL Valve Repair Trial: Comparing Two Transcatheter Treatments for Leaky Heart Valves
Plain English Summary
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial is a Not Applicable clinical trial sponsored by Edwards Lifesciences studying Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation. This trial tests the Edwards PASCAL system, a new device for repairing leaky mitral valves, against an existing device called MitraClip. It is for adults with leaky mitral valves (mitral regurgitation) who are considered too high-risk for open-heart surgery, or who have leaky valves due to heart failure. Participation involves receiving either the PASCAL system or MitraClip through a catheter-based procedure, followed by regular check-ups. The main alternative is open-heart surgery, or managing symptoms with medication if a procedure is not suitable. The trial aims to enroll 1247 participants.
Official Summary
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)
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who can consent and follow study instructions. Patients deemed too high-risk for open-heart surgery by a heart team (for one group). Patients with leaky mitral valves (grade 3+ or 4+) and specific valve anatomy suitable for repair. Patients with functional mitral regurgitation who are on standard heart failure medications (for another group). This trial is studying Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures will tell us if the Edwards PASCAL system is as safe and effective as the MitraClip in reducing mitral regurgitation and avoiding serious complications within a specific t The specific primary outcome measures are: PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). (30 days.); PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. (6 months); PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. (From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it compares a new device for minimally invasive mitral valve repair against a current standard, aiming to improve treatment options for patients with leaky heart valves who This research targets Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation, where improved treatment options are needed.
Investor Insight
This trial signals strong investment interest in transcatheter mitral valve repair, a growing market driven by an aging population and the limitations of surgical options, with the potential for signi The large enrollment target of 1247 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the risks and benefits of both the Edwards PASCAL system and the MitraClip, and how they compare to surgery for your specific condition. Participation involves a procedure where a device is delivered through a catheter to repair your valve, followed by regular clinic visits and tests to monitor your heart function. Be prepared for potential follow-up appointments and tests, including echocardiograms (ultrasound of the heart) and possibly other imaging or functional tests. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 1,247 participants
Interventions
- DEVICE: Edwards PASCAL System — Transcatheter mitral valve repair with the Edwards PASCAL System
- DEVICE: Abbott Mitraclip System — Transcatheter mitral valve repair with the Abbott Mitraclip System
Primary Outcomes
- PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). (30 days.)
- PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. (6 months)
- PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. (From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up)
Secondary Outcomes
- Rates of various adverse events (6 months; 12 months)
- Functional Improvement (increase in 6 minute walk test in meters) (30 days , 6 months, 1 year)
- Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years (30 days , 6 months, 1 year, 2 year)
- Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years (30 days, 6 months, 1 year, 2 year)
- Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through (30 days, 6 months, 1 year, 2 year)
Full 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
Trial Locations
- Banner University Medical Center, Phoenix, Arizona, United States
- Abrazo Arizona Heart Hospital, Phoenix, Arizona, United States
- TMC Healthcare, Tucson, Arizona, United States
- Scripps Memorial Hospital La Jolla, La Jolla, California, United States
- Cedars Sinai Medical Center, Los Angeles, California, United States
- UC Irvine, Orange, California, United States
- Sutter Medical Center-Sacramento, Sacramento, California, United States
- Sutter Bay Area, San Francisco, California, United States
- Kaiser Permanente San Francisco, San Francisco, California, United States
- University of California, San Francisco, San Francisco, California, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT03706833?
NCT03706833 is a Not Applicable INTERVENTIONAL study titled "Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial." It is currently active, not recruiting and is sponsored by Edwards Lifesciences. The trial targets enrollment of 1247 participants.
What conditions does NCT03706833 study?
This trial investigates treatments for Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation. The primary condition under study is Degenerative Mitral Valve Disease.
What treatments are being tested in NCT03706833?
The interventions being studied include: Edwards PASCAL System (DEVICE), Abbott Mitraclip System (DEVICE). Transcatheter mitral valve repair with the Edwards PASCAL System
What does Not Applicable mean for NCT03706833?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03706833?
This trial is currently "Active, Not Recruiting." It started on 2018-11-30. The estimated completion date is 2031-06-30.
Who is sponsoring NCT03706833?
NCT03706833 is sponsored by Edwards Lifesciences. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03706833?
The trial aims to enroll 1247 participants. The trial status is active, not recruiting.
How is NCT03706833 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT03706833?
The primary outcome measures are: PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). (30 days.); PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. (6 months); PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. (From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03706833 being conducted?
This trial is being conducted at 20 sites, including Phoenix, Arizona; Tucson, Arizona; La Jolla, California; Los Angeles, California and 16 more sites (United States).
Where can I find official information about NCT03706833?
The official record for NCT03706833 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03706833. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03706833 testing in simple terms?
This trial tests the Edwards PASCAL system, a new device for repairing leaky mitral valves, against an existing device called MitraClip. It is for adults with leaky mitral valves (mitral regurgitation) who are considered too high-risk for open-heart surgery, or who have leaky valves due to heart failure.
Why is this trial significant?
This trial matters because it compares a new device for minimally invasive mitral valve repair against a current standard, aiming to improve treatment options for patients with leaky heart valves who
What are the potential risks of participating in NCT03706833?
The main risks include bleeding, stroke, damage to the heart or blood vessels, and the need for further procedures or surgery. Potential side effects include infection, allergic reactions, and issues related to the device itself, such as improper placement or function. There's a possibility that the repair may not be fully successful, or that complications could arise during or after the procedure. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03706833?
Ask your doctor about the risks and benefits of both the Edwards PASCAL system and the MitraClip, and how they compare to surgery for your specific condition. Participation involves a procedure where a device is delivered through a catheter to repair your valve, followed by regular clinic visits and tests to monitor your heart function. Be prepared for potential follow-up appointments and tests, including echocardiograms (ultrasound of the heart) and possibly other imaging or functional tests. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03706833 signal from an investment perspective?
This trial signals strong investment interest in transcatheter mitral valve repair, a growing market driven by an aging population and the limitations of surgical options, with the potential for signi This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving either the PASCAL system or MitraClip through a catheter-based procedure, followed by regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.