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AltaValve for Mitral Valve Regurgitation
Study Summary
This trial will test how safe and effective a new valve is for people who are at high risk for complications from open heart surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Find a Location
Who is running the clinical trial?
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- Your heart's pumping ability is very low, as shown by a test done within the past 90 days.I have had a mitral valve repair or replacement that does not affect AltaValve placement.Your healthcare professional has determined that you are at high risk for open-heart surgery.I have a health condition that may limit my life to under a year.I understand the study and follow medical advice.I am not pregnant nor planning to become pregnant during the study.I am allergic or cannot take aspirin, heparin, or Warfarin and there are no good alternatives for me.I have moderate to severe heart condition symptoms.You have a serious heart valve problem called severe MR, as confirmed by an echocardiogram.I am 18 years old or older.
- 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 current participant count for this experiment?
"With 15 total participants, the sponsor of this research, 4C Medical Technologies Inc., is running it from two major sites: Los Robles Regional Medical Center in Thousand Oaks and Brigham & Women's Hospital located in Boston."
Are there any current opportunities to participate in this experiment?
"According to clinicaltrials.gov, this medical research is currently open for enrolment. The protocol was initially published on December 4th 2019 and recently amended on November 16th 2022."
How many facilities are currently offering this clinical endeavor?
"Patients are currently being enrolled in this medical trial from 15 different sites, such as Los Robles Regional Medical Center in Thousand Oaks California, Brigham & Women's Hospital in Boston Massachusetts and Prairie Heart Institute in Springfield Illinois."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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