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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
Hospital Universitario Clinic I Provincial
Barcelona, Spain
To evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 12 months.
The primary endpoint of the study is to evaluate the percentage of HOCM patients with severe LVOT obstruction implanted with a CRT-P device that have symptomatic improvement at 12 months post-implant. The symptomatic improvement is a combined endpoint defined as: * An improvement of at least one New Yorl Heart Association (NYHA) functional class and * An improvement of 10 points in the Quality of Life (QoL) Questionnaire score and * An increase \>10% in bike exercise time in the steady state Cardiopulmonary Exercise Test (CPET).
Time frame: 12 months
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