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 |
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Heart Failure Left Bundle-Branch Block Systolic Dysfunction | Device: Optimised MultiSite Pacing Device: Standard biventricular pacing | Not Applicable |
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 |
Arm | Intervention/treatment |
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Placebo Comparator: Standard biventricular pacing
Cardiac resynchronization therapy (CRT) devices will be programmed as per standard biventricular pacing settings
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Device: Standard biventricular pacing
Conventional programming settings using biventricular pacing will be used
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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.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter H Waddingham, MBBS BSc | 02037658635 | p.waddingham@nhs.net | |
Contact: Victoria Baker, BA | 02037658635 | victoria.baker@bartshealth.nhs.uk |
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 |
Principal Investigator: | Anthony WC Chow, MBBS BSc MD | Study Chief Investigator |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 2, 2019 | ||||||||
First Posted Date ICMJE | May 6, 2019 | ||||||||
Last Update Posted Date | May 14, 2019 | ||||||||
Estimated Study Start Date ICMJE | July 2019 | ||||||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Sub-group outcome: assessment of LV activation timings with ECGi [ Time Frame: 1 month post implant ] Electrocardiographic imaging
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Optimised MultiSite Pacing Vector Study | ||||||||
Official Title ICMJE | 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 | ||||||||
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. |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | 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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
52 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2021 | ||||||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03938090 | ||||||||
Other Study ID Numbers ICMJE | 012604 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Barts & The London NHS Trust | ||||||||
Study Sponsor ICMJE | Barts & The London NHS Trust | ||||||||
Collaborators ICMJE | Boston Scientific Corporation | ||||||||
Investigators ICMJE |
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PRS Account | Barts & The London NHS Trust | ||||||||
Verification Date | April 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |