Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site

Conditions
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Heart Failure

Intervention / Treatment
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* Other: High Frequency ECG Mapping
* Other: Q-LV Measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines; In sinus rhythm; NYHA class II, III or IV Have reviewed, signed and dated an informed consent. Age 18 Exclusion Criteria: 1. Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance); 2. Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month; 3. Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; 4. Incessant ventricular tachyarrhythmia; 5. Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks; 6. Correctable valvular disease that is the primary cause of heart failure; 7. Indication for valve repair or replacement; 8. Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months); 9. On transplant waiting list; 10. Previous heart transplant; 11. Already included in another clinical study that could confound the results of this study; 12. Life expectancy less than 1 year; 13. Inability to understand the purpose of the study; 14. Unavailability for scheduled follow-up or refusal to cooperate; 15. Age of less than 18 years; 16. Pregnancy; 17. Drug addiction or abuse; 18. Under guardianship.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HF-ECG guided LV pacing site optimisation<br>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. | Other: High Frequency ECG Mapping<br>* A high frequency ECG map will be performed to assess the optimum left ventricular pacing site.<br>|
| Active Comparator: Q-LV guided LV pacing site optimisation<br>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. | Other: Q-LV Measurement<br>* Measurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Reverse Remodelling | Absolute difference in left ventricular end systolic volume greater than or equal to 10% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NYHA Class |  | 6 months | 
| Change in quality of life score | Assessment through Minnesota Living with Heart Failure Questionnaire | 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 |