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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biventricular pacing | Experimental | All patients will be pacing during two years |
|
| No Pacing during the first year | Active Comparator | No Pacing during the first year. In the second year all patients will be pacing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biventricular pacing | Device | All patients will be pacing during two years |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JOSEP BRUGADA, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| ANTONIO BERRUEZO, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic i Provincial de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| No Pacing | Device | No Pacing during the first year. In the second year all patients will be pacing |
|
|
| 1 and 2 years |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |