Study Summary
This trial will compare the safety and effectiveness of a new mitral valve device to treat heart failure with mild regurgitation to current standard care.
- Heart Failure
- Heart Disease
- Mitral Regurgitation
- Cardiovascular Disease
- Mitral Valve Regurgitation
- Heart Valve Disease
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: 12 months of follow-up, and any available data up to 24 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Control Group
1 of 2
Intervention Group
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: Carillon Mitral Contour System · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Schofer, Joachim, Tomasz Siminiak, Michael Haude, Jean P. Herrman, Jindra Vainer, Justina C. Wu, Wayne C. Levy, et al.. 2009. “Percutaneous Mitral Annuloplasty for Functional Mitral Regurgitation”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.109.849885.
- Siminiak, Tomasz, Justina C. Wu, Michael Haude, Uta C. Hoppe, Jerzy Sadowski, Janusz Lipiecki, Jean Fajadet, et al.. 2012. “Treatment of Functional Mitral Regurgitation by Percutaneous Annuloplasty: Results of the TITAN Trial”. European Journal of Heart Failure. Wiley. doi:10.1093/eurjhf/hfs076.
- Lipiecki, Janusz, Tomasz Siminiak, Horst Sievert, Jochen Müller-Ehmsen, Hubertus Degen, Justina C Wu, Christian Schandrin, et al.. 2016. “Coronary Sinus-based Percutaneous Annuloplasty as Treatment for Functional Mitral Regurgitation: The TITAN II Trial”. Open Heart. BMJ. doi:10.1136/openhrt-2016-000411.
- Lipiecki J, Siminiak T, Sievert H, Muller-Ehmsen J, Degen H, Wu JC, Schandrin C, Kalmucki P, Hofmann I, Reuter D, Goldberg SL, Haude M. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Open Heart. 2016 Jul 8;3(2):e000411. doi: 10.1136/openhrt-2016-000411. eCollection 2016.
- Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.
- 2018. "The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03142152.
Frequently Asked Questions
What is the estimated number of participants in this trial?
"Cardiac Dimensions, Inc. is in search of 300 individuals that fit the trial's entrance requirements to conduct this study at Banner University Tucson and University of California- San Francisco." - Anonymous Online Contributor
How many venues are participating in the experimental protocol?
"This clinical trial is available in 40 various medical locations, including Banner University Tuscon (Tuscon), University of California- San Francisco (San Francisco) and UCLA Medical Center (Los Angeles)." - Anonymous Online Contributor
Are there any remaining opportunities for participants to join this research?
"The details posted on clinicaltrials.gov suggest that this trial is still recruiting participants; it was first published on the 1st of January 2018, with its most recent update being issued in October 2021." - Anonymous Online Contributor
What is the objective of this experiment?
"This trial has been designed to measure the hierarchical clinical composite as its primary efficacy objective. A number of secondary outcomes have also been detailed, including changes in NYHA classification, regurgitant volume, and left ventricular end-diastolic volume over a 12 month time frame." - Anonymous Online Contributor