Comparing two methods for optimizing heart pacing in heart failure patients

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

This study is testing if a new method using high frequency ECG can help heart failure patients feel better after getting heart pacing treatment compared to the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University Hospital Birmingham (Academic / other)
• Locations: 1 site (Birmingham, West Midlands)
• Trial ID: NCT05829876 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of high frequency ECG guided optimization versus conventional Q-LV measurement guided optimization for left ventricular pacing site in patients receiving Cardiac Resynchronization Therapy (CRT). It aims to determine if the high frequency ECG approach leads to better heart function recovery after 6 months of treatment. Participants will be randomly assigned to one of the two methods and will be monitored for their response to the therapy. The study is being conducted at a single center with a total of 180 participants.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with heart failure classified as NYHA class II, III, or IV who are eligible for CRT device implantation.

Not a fit: Patients with previous pacemaker or CRT device implants, persistent atrial arrhythmias, or recent acute cardiac events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart function and quality of life for patients with heart failure receiving CRT.

How similar studies have performed: While there have been studies on CRT optimization, the specific comparison of high frequency ECG versus Q-LV measurement is a novel approach.

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.

Where this trial is running

Birmingham, West Midlands

• University Hospitals Birmingham — Birmingham, West Midlands, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Jamie Walton, BSc — University Hospitals Birmingham
• Study coordinator: Jamie Walton, Bsc

Conditions Heart Failure