NCT03938090

Optimised MultiSite Pacing Vector Study

Withdrawn NA Last updated 11 May 2025

What this trial tests

NA trial testing Optimised MultiSite Pacing in Heart Failure. Withdrawn.

Timeline

1 December 2019

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	Barts & The London NHS Trust
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Start date	1 December 2019
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Optimised MultiSite Pacing
• Standard biventricular pacing

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Left Bundle-Branch Block — all drugs for Left Bundle-Branch Block →
• Systolic Dysfunction — all drugs for Systolic Dysfunction →

Sponsor

Barts & The London NHS Trust — full company profile →

Who can join

18 and older, any sex, with Heart Failure or Left Bundle-Branch Block. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this clinical investigation is to evaluate the clinical benefits of an MultiSite pacing (MSP) with patient specific left ventricular vector optimization in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.

This clinical investigation is a single-center, prospective, two-arm, randomized 1:1, crossover study designed to evaluate the effectiveness of Optimized MSP CRT compared to conventional bi-ventricular pacing.

Data will be collected at enrolment, CRT implant procedure, hospital pre-discharge, one, three and six months post implant. Enrolment data collection will include demographics, cardiovascular history, medication, echocardiography measurements, heart failure quality of life questionnaire and six minute walk test distance.

CRT implant procedure data collection will include implanted system information, lead location and conduction times. The electrical conduction recording procedure will include surface ECG and device electrogram (EGM) recordings during various MSP vector pacing configurations at the time of CRT device implant.

Patients will also undergo simultaneous invasive pressure measurements using a left ventricular pressure wire to allow haemodynamic measurements (dP/dtmax) during various MSP vector pacing configurations.

Optimal MSP programming settings will be determined by the narrowest QRS duration recorded by 12 lead ECG and the greatest change in dP/dtmax by pressure wires study.

In a subgroup of patients (approximately 25 patients), non-invasive electrical activation data will be collected with electrocardiographic imaging (ECGi) within 45 days of the implant procedure.

Patients will then be randomized 1:1 to receive either standard biventricular pacing or Optimized MSP at their one-month follow-up (± 15 days) visit.

At the 3 months (± 15 days) post randomization follow up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. The patients will then undergo cross-over to the alternate randomization group with programming adjusted accordingly.

At the final, 6 months (± 15 days) post randomization follow-up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. This will mark the completion of the study for each patient.

The expected duration of enrolment is 18 months. The total duration of the clinical investigation is expected to be 25 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.