Clinical trial NCT05829876: Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.
Official title: Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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:

* 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);
* Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
* 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;
* Incessant ventricular tachyarrhythmia;
* Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks;
* Correctable valvular disease that is the primary cause of heart failure;
* Indication for valve repair or replacement;
* Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
* On transplant waiting list;
* Previous heart transplant;
* Already included in another clinical study that could confound the results of this study;
* Life expectancy less than 1 year;
* Inability to understand the purpose of the study;
* Unavailability for scheduled follow-up or refusal to cooperate;
* Age of less than 18 years;
* Pregnancy;
* Drug addiction or abuse;
* Under guardianship.

Primary outcomes:
measure: Left Ventricular Reverse Remodelling
timeFrame: 6 months
Secondary outcomes:
measure: Change in NYHA Class
timeFrame: 6 months
measure: Change in quality of life score
timeFrame: 6 months
measure: Change in left ventricular ejection fraction
timeFrame: 6 months
measure: Reduction in QRS duration
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
state: West Midlands
Study officials:
affiliation: University Hospitals Birmingham
name: Jamie Walton, BSc
role: PRINCIPAL_INVESTIGATOR
References: