Optimised MultiSite Pacing Vector Study

NCT03938090 | Withdrawn DMC FDA Device

• 1 other identifier: 012604
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Left Bundle-Branch Block; Systolic Dysfunction

Keywords

Cardiac Resynchronization Therapy; MultiSite Pacing

Outcome Measures

Primary Outcomes (1)

• 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.

  3 and 6 months post randomization

Secondary Outcomes (4)

• Acute changes in surface ECG QRS duration and morphology

  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

  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

  Pre-implant, 3 and 6 months post randomization

• Change in NYHA functional class

  Pre-implant, 3 and 6 months post randomization

Other Outcomes (1)

• Sub-group outcome: assessment of LV activation timings with ECGi

  1 month post implant

Study Arms (2)

Standard biventricular pacing

PLACEBO COMPARATOR

Cardiac resynchronization therapy (CRT) devices will be programmed as per standard biventricular pacing settings

Device: Standard biventricular pacing

Optimised MultiSite Pacing (MSP)

ACTIVE COMPARATOR

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

Interventions

Optimised MultiSite Pacing DEVICE

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.

Optimised MultiSite Pacing (MSP)

Standard biventricular pacing DEVICE

Conventional programming settings using biventricular pacing will be used

Standard biventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic Heart Failure (NYHA class I-IV) with QRS duration of 150ms or more with left bundle branch block and LVEF of 35% or less despite optimal medical therapy.
• Patients above 18 years of age
• Able to provide informed consent and willing to comply with study requirements
• Intrinsic QRS duration ≥ 150 ms
• Sinus (or atrial paced) rhythm with intact AV conduction (PR interval ≤250 ms)

You may not qualify if:

• Resting heart rate \> 100 bpm
• High degree AV Block (2nd or 3rd degree AV block)
• Documented persistent atrial arrhythmia at the moment of enrolment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
• Patients scheduled for AV node ablation to treat atrial arrhythmias
• Recent (\< 3 months) myocardial infarction, catheter ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate CRT programming changes in the opinion of the investigator
• Women who are pregnant or plan to become pregnant during the study course
• Known left ventricular thrombus

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

St Bartholomew's Hospital, Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony WC Chow, MBBS BSc MD

  Study Chief Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, two-arm, randomized 1:1, crossover study

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: December 1, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)