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New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram.
In this prospective, double-blind, study, the investigators will evaluate:
Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device.
Secondary endpoints:
For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nominal | Active Comparator | CRT device is programmed with the nominal values. |
|
| Narrow QRS | Experimental | CRT device is programmed by QRS optimization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device programming: nominal | Other | CRT device is programmed to nominal values |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic response | Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death. | 12 months |
| Pacing/sensing AV delay difference |
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Inclusion Criteria: patients with standard indication of cardiac resynchronization
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Arbelo, MD, PhD | Hospital Clinic Universitari de Barcelona | Study Chair |
| LluÃs Mont, MD, PhD | Hospital ClÃnic Universitari de Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29749935 | Derived | Trucco E, Tolosana JM, Arbelo E, Doltra A, Castel MA, Benito E, Borras R, Guasch E, Vidorreta S, Vidal B, Montserrat S, Sitges M, Berruezo A, Brugada J, Mont L. Improvement of Reverse Remodeling Using Electrocardiogram Fusion-Optimized Intervals in Cardiac Resynchronization Therapy: A Randomized Study. JACC Clin Electrophysiol. 2018 Feb;4(2):181-189. doi: 10.1016/j.jacep.2017.11.020. Epub 2018 Feb 1. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Programming optimization by QRS |
| Other |
CRT device is programmed by QRS optimization |
|
| 12 months |