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Transcatheter Valve Repair System
Edwards PASCAL System for Tricuspid Regurgitation (CLASP II TR Trial)
N/A
Recruiting
Led By Michael J. Mack, 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
New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months, 24 months
Awards & highlights
CLASP II TR Trial Summary
This trial will test a new device to treat tricuspid valve regurgitation in patients at high risk for surgery.
Who is the study for?
This trial is for adults with severe tricuspid regurgitation, a heart valve disease causing symptoms or hospitalization despite medical treatment. Candidates must be at intermediate or higher risk for surgery complications as assessed by a Heart Team and willing to follow the study's procedures.Check my eligibility
What is being tested?
The Edwards PASCAL Transcatheter Valve Repair System is being tested against Optimal Medical Therapy in patients with symptomatic severe tricuspid regurgitation who are not good candidates for surgery due to high risk of mortality.See study design
What are the potential side effects?
Potential side effects may include bleeding, infection risks associated with catheter-based procedures, possible damage to the heart or vessels where the device is implanted, irregular heartbeats, and in rare cases stroke or death.
CLASP II TR 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 moderate to severe heart issues or was hospitalized for heart failure in the last year.
CLASP II TR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)
Secondary outcome measures
1 Grade Reduction in TR Severity
All Cause Mortality
All-Cause Mortality
+10 moreCLASP II TR Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Single-Arm RegistryExperimental Treatment1 Intervention
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Group II: Edwards PASCAL System & OMTExperimental Treatment1 Intervention
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Group III: Optimal Medical Therapy (OMT)Active Control1 Intervention
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
60,704 Total Patients Enrolled
Charles Davidson, MDStudy ChairNorthwestern University
2 Previous Clinical Trials
326 Total Patients Enrolled
Michael J. Mack, MDPrincipal InvestigatorBaylor Scott and White Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had carotid surgery in the last 30 days.I have not had a cardioversion procedure in the last 30 days.The structure of your tricuspid valve makes it impossible for the device to be placed and work correctly.I am 18 years old or older.I have moderate to severe heart issues or was hospitalized for heart failure in the last year.You have a pacemaker or defibrillator leads in your heart that could interfere with the study treatment, or you had them implanted in the last 90 days before joining the study.I have not had any heart or blood vessel procedures in the last 30 days.I have heart issues related to tricuspid regurgitation that aren't improving with current treatment.I had a leadless pacemaker for my heart implanted within the last 30 days.I haven't had heart infection or needed antibiotics for any infection in the last 2 weeks.I need oxygen regularly or all the time at home.I have serious heart issues that haven't been treated.You have severe tricuspid regurgitation.I have a serious heart condition, such as cardiomyopathy or significant congenital heart disease.I have severe heart failure and may need a device or transplant.I have had a tricuspid valve repair or replacement that may affect new treatments.The condition of your tricuspid valve cannot be checked by a certain type of heart ultrasound.You have a significant mass or clot in your heart, as determined by a special heart test.I have had a blood clot in my leg or lung in the last 3 months.I do not need urgent surgery and have no planned heart surgeries or procedures in the next year.I have not had heart surgery in the last 3 months.I have a severe narrowing of my neck arteries, treated or not.I have severe heart valve issues.I am able to give consent and follow the trial's requirements without any issues.I am currently experiencing bleeding in my digestive tract.A doctor has determined that you have a high risk of death if you undergo tricuspid valve surgery.I have had a stroke recently.My heart condition is not due to aging or wear and tear.
Research Study Groups:
This trial has the following groups:- Group 1: Edwards PASCAL System & OMT
- Group 2: Optimal Medical Therapy (OMT)
- Group 3: Single-Arm Registry
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are clinicians recruiting participants for this research endeavor currently?
"As of the latest update on August 5th 2022, this clinical trial is actively seeking participants. The initial posting date was December 11th 2019."
Answered by AI
What results are expected from this experiment?
"This two-year clinical trial is monitoring a Composite endpoint to assess all-cause mortality, RVAD implantation or heart transplantations, tricuspid valve interventions, hospitalizations due to heart failure and Quality of Life improvements (as measured by KCCQ scores). Additionally, secondary outcomes such as Durable RVAD implantation/heart transplants, Health Status - SF-36 scores and Rates of various adverse events at the 30 day mark will be monitored."
Answered by AI
How many individuals are participating in this medical experiment?
"Affirmative, current information on clinicaltrials.gov demonstrates that this medical trial is actively recruiting patients to be part of the study. This experiment was first posted in December 2019 and has been updated as recently as August 2022. It requires 825 individuals across 58 different sites to participate."
Answered by AI
How many healthcare facilities are currently conducting this research?
"The recruitment of participants is underway at the University of Iowa Hospitals & Clinics, Pinnacle Health Cardiovascular Institute/UPMC Pinnacle, Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania as well as another 58 medical sites."
Answered by AI
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