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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
Data collection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | CRT-P Implant. Patients randomized in Treatment Group will have the device programmed to optimized DDD pacing |
|
| Control Group | Placebo Comparator | CRT-P Implant. Patients randomized in the control Group will have the device programmed to back-up pacing AAI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-P Implant | Device | All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 12 months |
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Inclusion Criteria:
6. Patient's age is 18 years or greater. 7. Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form.
8. Patients must be willing and able to comply with all study requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Brugada, Proffesor | Hospital Clinic I Provincial, Barcelona, Spain | Principal Investigator |
| Antonio Berruezo, Dr. | Hospital Clinic I Provincial, Barcelona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Clinic I Provincial | Barcelona | 08036 | Spain |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 11, 2022 | |
| Reset | Mar 14, 2022 | |
| Release | Nov 14, 2024 | |
| Reset | Jan 2, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 11, 2022 | Mar 14, 2022 | |||
| Nov 14, 2024 |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| Jan 2, 2025 |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |