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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

Optimised MultiSite Pacing Vector Study

Clinicaltrials.gov identifier NCT03938090

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted May 14, 2019

Study Description

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:Heart Failure
    Left Bundle-Branch Block
    Systolic Dysfunction
  • Intervention/Treatment: Device: Optimised MultiSite Pacing
    Device: Standard biventricular pacing
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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
Arms and interventions
Arm Intervention/treatment
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.
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
Outcome Measures
  • 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
  • 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
Contacts

Contact: Peter H Waddingham, MBBS BSc 02037658635 p.waddingham@nhs.net

Contact: Victoria Baker, BA 02037658635 victoria.baker@bartshealth.nhs.uk

Locations

United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust
London

Sponsors and Collaborators

Barts & The London NHS Trust

Boston Scientific Corporation

Investigators

Principal Investigator: Anthony WC Chow, MBBS BSc MD Study Chief Investigator

More Information
  • Responsible Party: Barts & The London NHS Trust
  • ClinicalTrials.gov Identifier: NCT03938090 History of Changes
  • 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
  • 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: Heart Failure Bundle-Branch Block