NCT01332162

CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.

Detailed description

In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.

Conditions

• Hypertrophic Obstructive Cardiomyopathy (HOCM)

Interventions

Type	Name	Description
DEVICE	Biventricular pacing	All patients will be pacing during two years
DEVICE	No Pacing	No Pacing during the first year. In the second year all patients will be pacing

Timeline

• Start date: 2013-06-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2011-04-08
• Last updated: 2016-10-20

Locations

1 site across 1 country: Spain