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Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT.
The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT.
This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Dyssynchrony positive | Active Comparator |
| |
| 2a: Dyssynchrony negative | Active Comparator |
| |
| 2b: Dyssynchrony negative | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiV ICD | Device | Biventricular ICD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in New York Heart Association (NYHA) class from baseline to 6 months | 6 months | |
| Change in Quality-of-Life score from baseline to 6 months | 6 months | |
| Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Schilling, MD, FRCP | Barts and the London NHS Trust, Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts and the London NHS Trust | London | EC1A 7BE | United Kingdom |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ICD |
| Device |
Implantable Defibrillator |
|
| 6 months |