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Cardiovalve for Mitral Valve Regurgitation (AHEAD Trial)
AHEAD Trial Summary
This trial is testing a new device to stop mitral valve regurgitation. The device will be evaluated for safety and performance over 30 days and 5 years.
AHEAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAHEAD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AHEAD Trial Design
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Who is running the clinical trial?
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- Your lung artery pressure is too high compared to your overall blood pressure.My doctors consider me a high risk for heart surgery.I have had surgery or a procedure on my mitral valve before.I am a heart transplant recipient or urgently need one.My kidneys are not working well, with a low creatinine clearance rate.My heart pumps blood effectively.I have a heart condition that hasn't been treated but needs surgery.I need heart surgery for a condition other than mitral valve disease.Your echocardiogram shows a valve area less than 0.3cm2.Your heart's left ventricle is larger than 75 millimeters.I am allergic to contrast dyes, heparin, blood thinners, nickel, or titanium.I have not had a heart device implant or revision within the last month.I have severe issues with my heart's right valve or its right chamber.You are not expected to live more than 1 year because of non-heart related health issues.You have severe heart failure.I cannot or do not want to give consent for the study.You cannot have a transesophageal echocardiography.I do not have very low blood pressure or heart-related shock needing emergency heart support.I am currently taking antibiotics for an infection.My heart condition limits my physical activity but I can still take care of myself.I need help with my daily activities due to my disability.I have an ongoing heart infection.I have a heart condition not caused by blocked arteries or heart muscle issues.I am recommended to have a special heart pacing device but don't have one yet.My heart valve issue is due to aging or wear and tear.I have not had a stroke or mini-stroke in the last 30 days.You have severe calcium buildup around the mitral valve, as shown by heart imaging tests.I have a severe narrowing in my neck arteries.I have been on heart failure medication as per guidelines for over 30 days.My heart valve problem is severe and causes symptoms.Your heart anatomy is not suitable for the Cardiovalve.Your CK-MB levels are higher than normal.You have a mass, blood clot, or infection in your heart as seen on an echocardiogram.My doctor expects I have less than one year to live due to my cancer.I am between 18 and 85 years old.My heart pumps well, with an LVEF of 30% or higher.
- Group 1: Cardiovalve Transfemoral Mitral Valve
- 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 is the participant capacity of this trial?
"Affirmative. Clinicaltrials.gov corroborates that this investigation is currently recruiting patients, which was first posted on March 26th 2019 and recently revised on July 28th 2021. 15 individuals must be recruited from two distinct clinical sites."
To whom does this clinical trial extend an invitation?
"This clinical trial is enrolling 15 individuals aged 18 to 84 who suffer from mitral valve insufficiency. Other requirements include a cardiac index greater than 2.0, an NYHA Functional Class between II-IVa, prior treatment with GDMT for heart failure in the preceding 30 days and being classified as high surgical risk by the Heart Team (minimum two MV cardiac surgeons, one interventional cardiologist, and one imaging expert)."
Is the current trial inclusive of elderly individuals over 75 years old?
"The lower age limit for qualification into this trial is 18, while the upper bound cutoff sits at 84."
Are there any opportunities still available for participants in this clinical examination?
"Indeed, according to clinicaltrials.gov, this medical research project is presently accepting applicants. It was first launched on March 26 2019 and has seen its last update on July 28 2021. There are 15 places open at 2 locations."
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