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Optimised MultiSite Pacing Vector Study

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ClinicalTrials.gov Identifier: NCT03938090
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Barts & The London NHS Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Heart Failure Left Bundle-Branch Block Systolic Dysfunction Device: Optimised MultiSite Pacing Device: Standard biventricular pacing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-center, prospective, two-arm, randomized 1:1, crossover study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multimodality Assessment of Acute and Long Term Response to Optimised MultiSite Pacing Cardiac Resynchronisation (MSP CRT) Devices Compared to Biventricular (BiV) CRT, in Patients With Heart Failure
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Standard biventricular pacing
Cardiac resynchronization therapy (CRT) devices will be programmed as per standard biventricular pacing settings
 Device: Standard biventricular pacing
Conventional programming settings using biventricular pacing will be used
Active Comparator: Optimised MultiSite Pacing (MSP)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Echocardiographic clinical response [ Time Frame: 3 and 6 months post randomization ]
    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.


Secondary Outcome Measures :
  1. Acute changes in surface ECG QRS duration and morphology [ Time Frame: Acute change in QRS duration with pacing compared to intrinsic QRS duration, measured during pacing programming protcol at device implant ]
    QRS duration changes with CRT programming optimisation

  2. Acute change in LV dP/dtmax [ Time Frame: Acute change in LV dP/dtmax with pacing compared to intrinsic rhythm, measured during pacing programming protcol at device implant ]
    Changes in LV contractility as assessed by pressure wire

  3. Change in exercise capacity by 6MWT distance [ Time Frame: Pre-implant, 3 and 6 months post randomization ]
    6 minute walk test distance

  4. Change in NYHA functional class [ Time Frame: Pre-implant, 3 and 6 months post randomization ]
    New York Heart Association Functional class


Other Outcome Measures:
  1. Sub-group outcome: assessment of LV activation timings with ECGi [ Time Frame: 1 month post implant ]
    Electrocardiographic imaging


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938090


Contacts
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Contact: Peter H Waddingham, MBBS BSc 02037658635 p.waddingham@nhs.net
Contact: Victoria Baker, BA 02037658635 victoria.baker@bartshealth.nhs.uk

Locations
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United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Contact: Peter H Waddingham, MBBS BSc    02037658635    p.waddingham@nhs.net   
Contact: Victoria Baker, BA    02037658635    victoria.baker@bartshealth.nhs.uk   
Sub-Investigator: Peter H Waddingham, MBBS BSc         
Principal Investigator: Anthony WC Chow, MBBS BSc MD         
Sponsors and Collaborators
Barts & The London NHS Trust
Boston Scientific Corporation
Investigators
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Principal Investigator: Anthony WC Chow, MBBS BSc MD Study Chief Investigator
More Information
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03938090    
Other Study ID Numbers: 012604
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No participant data will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Barts & The London NHS Trust:
Cardiac Resynchronization Therapy
MultiSite Pacing
Additional relevant MeSH terms:
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Heart Failure
Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
 Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes