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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Single-center, prospective, two-arm, randomized 1:1, crossover study|
|Masking:||Double (Participant, Investigator)|
|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|
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.
- 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.
- 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
- 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
- Change in exercise capacity by 6MWT distance [ Time Frame: Pre-implant, 3 and 6 months post randomization ]6 minute walk test distance
- Change in NYHA functional class [ Time Frame: Pre-implant, 3 and 6 months post randomization ]New York Heart Association Functional class
- Sub-group outcome: assessment of LV activation timings with ECGi [ Time Frame: 1 month post implant ]Electrocardiographic imaging
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
|Contact: Peter H Waddingham, MBBS BScemail@example.com|
|Contact: Victoria Baker, BAfirstname.lastname@example.org|
|St Bartholomew's Hospital, Barts Health NHS Trust|
|London, United Kingdom, EC1A 7BE|
|Contact: Peter H Waddingham, MBBS BSc 02037658635 email@example.com|
|Contact: Victoria Baker, BA 02037658635 firstname.lastname@example.org|
|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|