MitraClip™ device implantation for Mitral Valve Regurgitation
This trial is comparing the effectiveness of two treatments for severe primary MR in patients who are at moderate surgical risk.
- Mitral Valve Regurgitation
2 Primary · 5 Secondary · Reporting Duration: 2 Years
1 Treatment Group
1 of 1
500 Total Participants · 1 Treatment Group
Primary Treatment: MitraClip™ device implantation · No Placebo Group · N/A
Who is running the clinical trial?
Age 18+ · All Participants · 6 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Kaneko, Tsuyoshi, Sameer Hirji, Syed Zaid, Rudiger Lange, Jörg Kempfert, Lenard Conradi, Christian Hagl, et al.. 2021. “Mitral Valve Surgery After Transcatheter Edge-to-edge Repair”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2021.07.029.
- 2020. "MitraClip REPAIR MR Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04198870.
Frequently Asked Questions
Where in North America are trials being conducted involving this clinical research?
"For this clinical trial, 57 sites are operating. Selected locations include the Lankenau Institute for Medical Research in Wynnewood, Sentara Norfolk General Hospital in Norfolk, and University Hospitals Cleveland Medical Center in Cleveland." - Anonymous Online Contributor
Is the enrollment period for this research still open?
"Affirmative. Per the clinicaltrials.gov database, this research project is actively recruiting participants at 57 different medical centres. The investigation was posted on July 21st 2020 and was recently refreshed on October 31st 2022 with 500 total patients needed for enrollment." - Anonymous Online Contributor
How many participants are being recruited for this medical experiment?
"This clinical trial requires 500 qualified participants, who meet the criteria for inclusion. The medical centres hosting this study are Lankenau Institute for Medical Research in Wynnewood, Pennsylvania and Sentara Norfolk General Hospital in Norfolk, Virginia." - Anonymous Online Contributor
What are the primary aims of this medical trial?
"According to Abbott Medical Devices, the clinical trial's principal aim is a 2-year evaluation of all-cause mortality, stroke risk, cardiac hospitalization events or acute kidney injury necessitating renal replacement therapy (excluding any cardiac episodes within 30 days post treatment). Additionally, this study will also assess secondary endpoints such as severe symptomatic mitral stenosis at 1 year and time spent in care from index procedure to home discharge for both Device and Control groups. Lastly, investigators are looking into the proportion of patients being discharged to their homes after treatment amongst both experimental arms." - Anonymous Online Contributor