CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

Study Overview
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Brief Summary
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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
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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.

Official Title
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CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

Conditions
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Hypertrophic Obstructive Cardiomyopathy (HOCM)

Intervention / Treatment
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* Device: Biventricular pacing
* Device: No Pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms Exclusion Criteria: HOCM intraventricular gradient < 50mmHg LV ejection fraction < 50% mild symptoms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biventricular pacing<br>All patients will be pacing during two years | Device: Biventricular pacing<br>* All patients will be pacing during two years<br>* Other names: Anthem PM3112. St. Jude Medical;|
| Active Comparator: No Pacing during the first year<br>No Pacing during the first year. In the second year all patients will be pacing | Device: No Pacing<br>* No Pacing during the first year. In the second year all patients will be pacing<br>* Other names: Anthem PM3112. St. Jude Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg). | Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg) | 1 and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade. | Change from Baseline in Clinical evaluation (New York Heart Association(NYHA), Quality of life Questionnaire (QoL), 6 Minutes Walk Test (6MWT)), interventricular septum thickness, posterior wall thickness, provoked left ventricular outflow tract gradient, mitral regurgitation grade. | 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrophic Obstructive Cardiomyopathy (HOCM), Pacing