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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
Study Summary
This trial is a study to see if the Leaflex Performer is safe and effective in treating patients with aortic stenosis.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in 6 minute walk test
Change in aortic valve area
Change in pressure gradients
+4 moreTrial 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost figure of participants in this clinical trial?
"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical study, initially posted June 16th 2021, is currently seeking participants. The trial requires 15 volunteers from 3 different facilities to be enrolled into the program."
Answered by AI
Are there currently vacancies to participate in this medical experiment?
"Data from clinicaltrials.gov demonstrates that this trial is actively seeking participants, with its first post dated June 16th 2021 and most recent update occurring on July 28th 2022."
Answered by AI
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