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TMVR for Mitral Valve Regurgitation (APOLLO Trial)
APOLLO Trial Summary
This trial is testing a new medical device. Everyone enrolled in the trial will receive the device.
APOLLO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAPOLLO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.APOLLO Trial Design
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Who is running the clinical trial?
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- My heart's pumping ability is very low.I need surgery as soon as possible.I have severe calcium buildup on my heart's mitral valve.My body has physical conditions that prevent certain medical procedures.My blood pressure and heart rate are stable.A team of heart specialists agrees I can't have standard heart valve treatments.I have moderate to severe symptoms from a leaky heart valve.
- Group 1: Primary Cohort- TMVR
- Group 2: Mitral Annular Calcification -TMVR
- 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
How many people are participating in this experiment?
"For this research trial to be successful, 1350 qualified participants must join. Medtronic Cardiovascular is the project sponsor and will manage the proceedings from various points of service such as Mercy Medical Center in Des Moines, Iowa and NYU Winthrop Hospital in Mineola, New york."
What are the objectives of this clinical investigation?
"Over the course of a year, the primary outcome that will be assessed is MAC Cohort. Secondary outcomes include Cardiovascular hospitalizations, all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation and deep wound infection as well as reoperation or reintervention and major bleeding (Composite). Quality of Life Improvement will also be evaluated via SF-12 and KCCQ metrics."
Are there any opportunities to participate in this trial currently available?
"Clinicaltrials.gov informs us that this clinical trial, initiated on October 23rd 2017, is still accepting participants. The latest update was posted on August 5th 2022."
Are there plentiful venues conducting this medical trial on a state level?
"The trial is recruiting at 55 locations, including the cities of Des Moines, Mineola and Wynnewood. It is important to choose a site as nearby as possible in order to minimize travel obligations for participants."
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