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Embolic Protection Devices for Preventing Embolism (ProtectH2H Trial)
ProtectH2H Trial Summary
This trial looks at the safety and effectiveness of a new medical treatment in multiple locations.
ProtectH2H Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowProtectH2H Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ProtectH2H Trial Design
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Who is running the clinical trial?
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- I do not have dementia or any cognitive issues that prevent me from understanding or following study instructions.I am not planning any heart surgery around the time of my TAVR procedure.You have a strong allergic reaction to certain medications that cannot be treated with pre-medication.I am 18 years old or older.I have agreed to undergo a TAVR procedure.I have severe aortic calcification or other specific aorta conditions.I have a heart valve replacement or severe mitral valve leak.I have a current blood disorder that needs treatment.You have abnormal masses or clots in your heart or aorta, as seen on an echocardiogram.I do not have severe heart problems like cardiogenic shock or need help to maintain my blood pressure.I do not have an active infection or endocarditis.I have had emergency surgery recently.I have a progressive brain disorder or had a serious head injury with lasting effects.I am approved for a heart valve replacement due to severe narrowing.I am not scheduled for a TAVR procedure through the leg.My blood clots too easily and heparin doesn't help.I had a heart attack less than 30 days ago.I have not had a stroke in the last 6 months.I have not had a stomach ulcer or stomach bleeding in the last 3 months.Your heart's pumping ability is very low, less than 20%.I had a procedure to open my neck artery less than 6 months ago.I had a balloon valvuloplasty within the last 30 days.I was born with a one-flap aortic valve.I have a dialysis access point like a shunt, graft, or fistula.I have a thickened heart muscle, with or without blockage.I have a bleeding disorder that hasn't been treated.I have severe kidney problems or am on dialysis.
- Group 1: Emboliner Embolic Protection Device
- Group 2: Sentinel Cerebral Protection System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What potential risks accompany the use of Emboliner Embolic Protection Device?
"Due to the nature of this Phase 2 clinical trial, which has some data affirming safety but none that can prove efficacy, our team at Power have conferred Emboliner Embolic Protection Device with a score of 2."
How many volunteers are participating in this experiment?
"Affirmative. Clinicaltrials.gov displays that this research endeavor, which was first uploaded on May 4th 2023, is currently recruiting participants. The investigators are looking to recruit 540 volunteers from 2 different medical sites."
Is recruitment for this research program still open?
"Affirmative. Clinicaltrials.gov's data reflects that this clinical trial is currently in the process of recruiting participants; it was originally posted on May 4th 2023 and subsequently revised on May 17th 2023. 540 patients must be sourced from two separate medical centres."
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