NCT01614717

Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY

Triple Chamber Pacing in HOCM Patients - TRICHAMPION STUDY

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation is a prospective, randomized, single-blinded and multicenter design. The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular (BiV) pacing in severely symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients with severe Left Ventricular Outflow Tract (LVOT) obstruction implanted with a Cardiac Resynchronization Therapy - Pacing (CRT-P) device. Randomization * Implant will be performed (CRT-P). * Patients will be randomized 1:1 to either Treatment Group (Optimized Biventricular (DDD) pacing) or Control Group (Back-up Atrial (AAI) pacing) during the first 12 months: * Treatment Group. The patient´s device is programmed to optimized DDD BiV pacing * Control Group. The patient´s device is programmed to back-up pacing AAI. * After 12 months, the patients initially randomized to the Treatment Group (Optimized DDD Pacing) will continue in the same group. The patients initially randomized to Control Group (AAI Back-up Pacing) will be changed to the Treatment Group (Optimized DDD Pacing). And all the patients will be followed 12 months more.

Detailed description

Data collection * In clinic Follow ups (FU): Enrollment, Baseline, Implant, Pre-discharge, 3 months (M), 12 M, 15 M and 24 M. * Phone call FU: 6 M, 9 M, 18 M and 21 M.

Conditions

• Hypertrophic Cardiomyopathy With Obstruction

Interventions

Type	Name	Description
DEVICE	CRT-P Implant	All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group

Timeline

• Start date: 2014-07-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2012-06-08
• Last updated: 2020-12-21

Locations

1 site across 1 country: Spain