Cardiac Contractility Modulation in Chagas Heart Disease

Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent morbidity. While CRT and drug treatment have been advocated and implemented without much success to improve the clinical condition of patients with CCC, there is no consistent scientific evidence on the role of cardiac contractility modulation (CCM) as a form of adjuvant treatment for heart failure in patients with CCC. The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.

NCT Number	NCT05519046
Lead Sponsor	InCor Heart Institute Collaborators: Impulse Dynamics, I2medi Comercial Medica LTDA
Conditions	Chagas Cardiomyopathy, Heart Failure, Systolic Dysfunction, Right Bundle Branch Block and Left Anterior Fascicular Block, Right Bundle Branch Block and Left Posterior Fascicular Block
Enrollment	60 participants
Start Date	2022-05-25
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-08