The TITAN II study achieved its endpoint and showed significant improvements in echo parameters and patient function.
TITAN II was a single-arm study designed to assess the safety and efficacy of an updated version of the Carillon system. Inclusion and exclusion criteria were similar to those in TITAN. Patients had symptomatic congestive heart failure (NYHA class ≥2), MR grade 2+ to 4+, a dilated LV (LVEDD >55 mm) and an ejection fraction <40%. Quantitative assessments of MR were performed by an independent core echo laboratory, and MAE were reviewed by an independent data and safety monitoring board. In total, 36 patients were enrolled; 30 received a permanent implant.
The TITAN study met its endpoint and showed the Carillon device can significantly and safely reduce FMR severity in heart failure patients, resulting in significant favorable reverse LV remodeling over 12 months and improved measures of clinical outcomes over 24 months.
The TITAN study was a prospective, non-randomized multi-center European study. The objective of the study was to determine if the Carillon device could safely and effectively reduce FMR and yield a durable long-term clinical benefit. Follow-up included typical clinical and echo assessments through 1 year and implanted patients had an additional clinical follow-up assessment at 2 years. The study was rigorously conducted with oversight by independent parties including an echo core lab, clinical events committee, and a data and safety monitoring board. Key inclusion criteria included MR grade 2+ to 4+, NYHA Class II-IV and LVEF <40%.
Of the 53 patients enrolled in the study, 36 underwent permanent implant of the device. In 17 patients, the device was recaptured (due to transient coronary impingement (n=8) or <1 grade FMR reduction (n=9). These non-implant patients were followed as a comparator group.
The first-in-human AMADEUS study met its endpoint and demonstrated successful deployment of the Carillon device and a significant reduction in FMR.
AMADEUS was a single-arm, first-in-human study designed to evaluate the safety and feasibility of the Carillon system. The study utilized several independent bodies to minimize bias and increase rigor, including a blinded echo core lab, clinical events committee, and data and safety monitoring board. Key inclusion criteria included moderate to severe FMR, NYHA class II-IV, LVEDD >55mm, and ejection fraction <40% receiving sustained stable and optimal HF medication regimen. The study enrolled 48 patients with the device successfully implanted in 30 patients. At six months, the degree of FMR reduction among five different quantitative echo measures ranged from 22-32%.
Ongoing Pivotal IDE Study
We hope you and your loved ones are safe as we all manage the impacts of the COVID-19 pandemic. For the ongoing CARILLON Trial, protecting the safety of patients and researchers is paramount. In this spirit, Cardiac Dimensions has temporarily paused new trial enrollment. We are continually monitoring the global pandemic and will resume trial enrollment when it is safe to do so.
Please send any inquiries to CARILLON@cardiacdimensions.com
If you have heart failure, you know how this condition affects your quality of life. Simple daily activities like preparing meals, visiting with friends, or even moving from room to room can require major effort and leave you exhausted. An estimated 26 million people suffer from heart failure worldwide, and the number is growing rapidly.
Nearly 75% of heart failure sufferers also have a leaky mitral valve, a condition known as mitral regurgitation (MR). Unfortunately, this further compromises the function of the heart – causing your heart failure to worsen over time.
If you struggle with heart failure symptoms or have been told you have a leaky valve, you may qualify for a new clinical study. The study is for the Carillon Mitral Contour System, an investigational implant designed to reshape the mitral valve and reduce leakage through a non-surgical approach.
Trial sites are currently located in the U.S., U.K., Poland, Greece and France. Interested patients may find out more about the trial at Clinical Trials (click here).