Heart Failure. Clinical Trial
Official title:
Latin America Cardiac Resynchronization Therapy Study
The Latin America CRT Study is a prospective, multicenter, interventional post-market release study conducted in Latin America. The geography includes Puerto Rico and the Caribbean, Mexico and Central America, and South America.
The purpose of this study is to provide local evidence regarding Cardiac Resynchronization
Therapy (CRT), in both pacing and defibrillation devices across Latin America. The primary
objective will focus on changes in left ventricular heart size and function measurements in
subjects receiving CRT therapy. The following additional parameters will also be collected:
- Data on referral patterns in Latin America;
- Data on device implant (including delivery system, device information, and lead
information);
- Clinical data on subject outcomes and changes (improved, unchanged, or worsened) in
heart failure status as assessed by heart failure (HF) hospitalizations, New York Heart
Association (NYHA) class, mortality, and Quality of Life (QOL) measured by the Patient
Global Assessment;
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device
|
N/A | |
| Completed |
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Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics
|
N/A |