An interventional study of Optimised MultiSite Pacing and Standard biventricular pacing in Heart Failure, Left Bundle-Branch Block and Systolic Dysfunction, sponsored by Barts & The London NHS Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Barts & The London NHS Trust · Not applicable, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cardiac resynchronization therapy (CRT) devices will be programmed as per standard biventricular pacing settings
Device: Standard biventricular pacing
Cardiac resynchronization therapy (CRT) devices will be programmed as per optimal MSP programming settings; determined by greatest change in dP/dtmax and narrowest QRS duration.
Device: Optimised MultiSite Pacing
The intervention includes using optimal programming settings with MultiSite pacing configurations via the patient's CRT device. The device in use is the same for each arm, the only changes are the programming settings.
Conventional programming settings using biventricular pacing will be used
Echocardiographic clinical response
Response to optimised MSP CRT compared to BiV CRT defined by LV systolic volume reduction of greater than 15% (indicative of "reverse remodelling") at completion of follow up.
Time frame: 3 and 6 months post randomization
Acute changes in surface ECG QRS duration and morphology
QRS duration changes with CRT programming optimisation
Time frame: Acute change in QRS duration with pacing compared to intrinsic QRS duration, measured during pacing programming protcol at device implant
Acute change in LV dP/dtmax
Changes in LV contractility as assessed by pressure wire
Time frame: Acute change in LV dP/dtmax with pacing compared to intrinsic rhythm, measured during pacing programming protcol at device implant
Change in exercise capacity by 6MWT distance
6 minute walk test distance
Time frame: Pre-implant, 3 and 6 months post randomization
Change in NYHA functional class
New York Heart Association Functional class
Time frame: Pre-implant, 3 and 6 months post randomization
Sub-group outcome: assessment of LV activation timings with ECGi
Electrocardiographic imaging
Time frame: 1 month post implant
Plan to share: No — No participant data will be shared with other researchers
No publications or documents are linked to this record.
Ran from Dec 2019 to primary completion in Nov 2023, 47 months.
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This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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