Clinical trials & studies
At TMC Health, we are conducting a variety of exciting research studies across multiple fields. Explore our full list of ongoing studies for additional details, or contact us by phone or email if you or your patient are interested in participating in a trial.
Ongoing studies (by indication)
Aortic stenosis
ENVISION assesses safety/effectiveness of Navitor TAVI in symptomatic severe aortic stenosis at intermediate/low surgical risk and valve‑in‑valve use for failed bioprosthetic valves in high‑risk patients.
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Atrial fibrillation
The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.
Heart failure
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
Mitral regurgitation / stenosis
A prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
Study evaluating feasibility, safety and performance of the HighLife trans‑septal transcatheter mitral valve in patients with moderate‑severe and severe mitral regurgitation at high surgical risk.
Prospective multicenter study of high‑risk patients with severe mitral annular calcification (MAC) and symptomatic mitral dysfunction, comparing transseptal valve‑in‑MAC treatment vs. medical therapy and registry groups.
Tricuspid regurgitation
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System.
Type 1 diabetes
Trialnet's Natural History Study screens relatives of people with type 1 diabetes to identify those at risk for developing the disease by testing for the presence of antibodies associated with diabetes.
