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Transcatheter Valve Repair System
Transcatheter Valve Repair for Mitral Regurgitation (CLASP IID/IIF Trial)
N/A
Recruiting
Led By Robert Smith, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eighteen (18) years of age or older
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Awards & highlights
CLASP IID/IIF Trial Summary
This trial is testing a new transcatheter valve repair system in patients with either degenerative or functional mitral regurgitation who are at high risk for mitral valve surgery.
Who is the study for?
This trial is for adults with severe mitral valve regurgitation who are at high risk for surgery. Candidates must be on stable heart medications, able to consent and comply with follow-up visits, have suitable valve morphology, and not be pregnant. Exclusions include prior mitral procedures (except some repairs), significant untreated coronary disease, recent stroke or DVT/PE, severe lung disease, or life expectancy under 12 months.Check my eligibility
What is being tested?
The trial tests the Edwards PASCAL Transcatheter Valve Repair System against the Abbott MitraClip System in patients with degenerative or functional mitral regurgitation deemed too risky for surgery. It aims to establish safety and effectiveness of these minimally invasive heart valve repair options.See study design
What are the potential side effects?
Potential side effects may include complications related to catheter insertion such as bleeding or infection, adverse reactions to anesthesia used during the procedure, damage to the heart valves from device placement or operation failure leading to inadequate reduction of regurgitation.
CLASP IID/IIF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had heart failure or high heart stress levels recently.
CLASP IID/IIF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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).
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.
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.
Secondary outcome measures
Functional Improvement (increase in 6 minute walk test in meters)
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through
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
+2 moreCLASP IID/IIF Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Edwards PASCAL System - Single-Arm RegistryExperimental Treatment1 Intervention
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.
Group II: Edwards PASCAL System - CLASP IIFExperimental Treatment1 Intervention
Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation
Group III: Edwards PASCAL System - CLASP IIDExperimental Treatment1 Intervention
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
Group IV: Abbott Mitraclip System - CLASP IIDActive Control1 Intervention
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
Group V: Abbott Mitraclip System - CLASP IIFActive Control1 Intervention
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation
Find a Location
Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
60,327 Total Patients Enrolled
Robert Smith, MDPrincipal InvestigatorThe Heart Hospital Baylor Plano
1 Previous Clinical Trials
25 Total Patients Enrolled
Brian K Whisenant, MDPrincipal InvestigatorIntermountain Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe chronic obstructive pulmonary disease.I am not pregnant nor planning to become pregnant in the next year, and I agree to use contraception.I have had a stroke recently.I have active rheumatic heart disease.I have a severe narrowing in my neck arteries that hasn't been treated.You cannot have a transesophageal echocardiogram (TEE) for medical reasons, or if the initial TEE test does not work.My heart valve and its function are suitable for the study.Your heart's pumping ability is between 20% and 50%.The medical team has decided that the patient is not safe to have mitral valve surgery (this applies only to the CLASP IID group).I am on a stable heart failure medication regimen.The medical team has decided that you should have a procedure to repair your mitral valve using either PASCAL or MitraClip.I am 18 years old or older.My heart's mitral valve shape may not allow certain treatments.I do not need any urgent surgery or have any planned heart surgery in the next year.I have had surgery or a procedure on my mitral valve, but not for chord replacement or annuloplasty.I have severe heart valve issues needing surgery.I have had a recent blood clot in my leg or lung.My doctors have decided I'm at high risk for mitral valve surgery.I have had heart failure or high heart stress levels recently.You have severe leakage of the heart's mitral valve, as seen in a heart ultrasound.I have severe heart failure needing advanced treatment like a heart pump or transplant.I have serious heart artery problems that haven't been treated.I need treatment for a severe heart valve problem.I have a severe heart valve problem.
Research Study Groups:
This trial has the following groups:- Group 1: Edwards PASCAL System - Single-Arm Registry
- Group 2: Edwards PASCAL System - CLASP IIF
- Group 3: Edwards PASCAL System - CLASP IID
- Group 4: Abbott Mitraclip System - CLASP IID
- Group 5: Abbott Mitraclip System - CLASP IIF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mitral Valve Regurgitation Patient Testimony for trial: Trial Name: NCT03706833 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current cohort size of this investigation?
"Affirmative. Data provided on clinicaltrials.gov suggests that the trial, which was initially posted in November 2018, is actively seeking participants to enrol. The study requires 1275 patients from 77 medical sites across the country."
Answered by AI
In which locations can this research be accessed?
"At present, the study is enrolling participants at 77 various sites, with a few being in San Diego, Weston and Washington. To reduce travel costs whilst involved in this trial it is essential to secure an appointment close by your location."
Answered by AI
What are the primary objectives of this experiment?
"The primary outcome of this trial, monitored from randomization to heart failure hospitalization or death, will assess the degree to which PASCAL is less inferior than Mitraclip in terms of MR severity reduction as measured by echocardiography. Secondary objectives include rates of various adverse events at 6 and 12 months post-intervention, functional improvement (quality of life) assessed via the Short Form Health Survey (SF-36), and an evaluation of the increase in individuals' six minute walk test scores."
Answered by AI
Are there any openings for enrollment in this clinical trial?
"Clinicaltrials.gov affirms that this medical study is currently searching for volunteers, having first been posted on November 30th 2018 and last updated on November 3rd 2022."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
Louisiana
How old are they?
18 - 65
What site did they apply to?
Oschner Medical Center
Beth Israel Deaconess Medical Center
Oklahoma Cardiovascular
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I received a porcine mitral valve replacement in October 2011. The valve is now failing. Angiograms, CT scan of my heart, echocardiograms and TEE are recent and in EPIC/MYCHART. The TEE indicates one of the petals of the replacement valve has split resulting in leaking of the valve.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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