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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: High Frequency ECG Mapping; Other: Q-LV Measurement

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie Walton, Bsc; Phone Number: 01213712535; Email: jamie.walton@uhb.nhs.uk
• Study Contact Backup: Name: Francisco Leyva-Leon, MD; Phone Number: 01213712500; Email: francisco.leyva@uhb.nhs.uk

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2GW
      • Recruiting
      • University Hospitals Birmingham
      • Contact: Francisco Leyva-Leon, MD; Phone Number: 01213712500; Email: francisco.leyva@uhb.nhs.uk
      • Contact: Jamie Walton, Bsc (Hons) Cardiac Physiology; Phone Number: 01213712535; Email: jamie.walton@uhb.nhs.uk
      • Principal Investigator: Francisco Leyva-Leon, MD
      • Sub-Investigator: Jamie Walton, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 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
Change in NYHA Class	NYHA Class Assessment	6 months

Collaborators and Investigators

• Sponsor: University Hospital Birmingham
• Investigators: Principal Investigator: Jamie Walton, BSc, University Hospitals Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RRK7831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No