NCT05829876

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 21, 2024

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

April 13, 2023

Last Update Submit

August 19, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Reverse Remodelling

    Absolute difference in left ventricular end systolic volume greater than or equal to 10%

    6 months

Secondary Outcomes (4)

  • Change in NYHA Class

    6 months

  • Change in quality of life score

    6 months

  • Change in left ventricular ejection fraction

    6 months

  • Reduction in QRS duration

    6 months

Study Arms (2)

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.

Other: High Frequency ECG Mapping

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.

Other: Q-LV Measurement

Interventions

High Frequency ECG MappingOTHER

A high frequency ECG map will be performed to assess the optimum left ventricular pacing site.

HF-ECG guided LV pacing site optimisation
Q-LV MeasurementOTHER

Measurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site.

Q-LV guided LV pacing site optimisation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham

Birmingham, West Midlands, B15 2GW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jamie Walton, BSc

    University Hospitals Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Walton, Bsc

CONTACT

01213712535jamie.walton@uhb.nhs.uk

Francisco Leyva-Leon, MD

CONTACT

01213712500francisco.leyva@uhb.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 26, 2023

Study Start

October 31, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

August 21, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)