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The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment.
Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function.
The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HF-ECG guided LV pacing site optimisation | Experimental | Participants will have the left ventricular pacing site programmed based on the results of HF-ECG mapping to locate the area of latest activation and best pattern of paced resynchronisation. |
|
| Q-LV guided LV pacing site optimisation | Active Comparator | Participants will have the left ventricular pacing site programmed based on the results of Q-LV measurement to locate the area of latest activation. This is the standard of care method for pacing site optimisation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Frequency ECG Mapping | Other | A high frequency ECG map will be performed to assess the optimum left ventricular pacing site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Reverse Remodelling | Absolute difference in left ventricular end systolic volume greater than or equal to 10% | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NYHA Class | NYHA Class Assessment | 6 months |
| Change in quality of life score | Assessment through Minnesota Living with Heart Failure Questionnaire |
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Inclusion Criteria:
• Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Walton, Bsc | Contact | 01213712535 | jamie.walton@uhb.nhs.uk | |
| Francisco Leyva-Leon, MD | Contact | 01213712500 | francisco.leyva@uhb.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Jamie Walton, BSc | University Hospitals Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham | Recruiting | Birmingham | West Midlands | B15 2GW | United Kingdom |
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Participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization.
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| Q-LV Measurement | Other | Measurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site. |
|
| 6 months |
| Change in left ventricular ejection fraction | Improved left ventricular ejection fraction | 6 months |
| Reduction in QRS duration | QRS duration measured on 12 lead ECG | 6 months |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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