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Leaflex™ Performer for Aortic Valve Stenosis
N/A
Waitlist Available
Research Sponsored by Pi-cardia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 6 and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is a study to see if the Leaflex Performer is safe and effective in treating patients with aortic stenosis.
Who is the study for?
This trial is for patients with severe aortic stenosis who have symptoms and are operable but not immediately recommended for valve replacement. Participants must be willing to follow the study schedule and provide consent. Exclusions include recent heart attack, low heart function, unstable health conditions, short life expectancy, certain heart diseases, ongoing serious infections, blood disorders or coagulopathy.
What is being tested?
The Leaflex™ Performer is being tested in this early feasibility study to evaluate its safety and performance in treating symptomatic severe aortic stenosis. This single-arm trial will monitor participants before and after the procedure at multiple intervals up to one year post-procedure.
What are the potential side effects?
While specific side effects of the Leaflex™ Performer are not listed here, potential risks may include complications related to heart procedures such as bleeding, infection risk around the treated area or within the body generally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in 6 minute walk test
Change in aortic valve area
Change in pressure gradients
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Leaflex™ PerformerExperimental Treatment1 Intervention
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Who is running the clinical trial?
Pi-cardiaLead Sponsor
4 Previous Clinical Trials
210 Total Patients Enrolled
3 Trials studying Aortic Valve Stenosis
145 Patients Enrolled for Aortic Valve Stenosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a heart attack within the 6 weeks before the study.Your heart's pumping ability is very low.You have unstable blood pressure or heart rate.You are not expected to live for more than 12 months.You have a type of heart condition called hypertrophic cardiomyopathy with a blockage.You have a significant problem with your blood cell count or a history of bleeding disorders.You have moderate or severe aortic regurgitation.You have heart or artery problems that need to be treated, or you have had treatment for artery disease in the past month.You had a procedure to open up your heart valve within the last 3 months.You have a serious heart valve problem that needs treatment, but the medical team does not recommend immediate surgery or a heart procedure.You had a stroke less than 12 months before the study.
Research Study Groups:
This trial has the following groups:- Group 1: Leaflex™ Performer
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.
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