Clinical trial NCT03938090: Optimised MultiSite Pacing Vector Study
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Left Bundle-Branch Block
Systolic Dysfunction
Keywords: Cardiac Resynchronization Therapy
MultiSite Pacing
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2019-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-center, prospective, two-arm, randomized 1:1, crossover study
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Echocardiographic clinical response
timeFrame: 3 and 6 months post randomization
Secondary outcomes:
measure: Acute changes in surface ECG QRS duration and morphology
timeFrame: Acute change in QRS duration with pacing compared to intrinsic QRS duration, measured during pacing programming protcol at device implant
measure: Acute change in LV dP/dtmax
timeFrame: Acute change in LV dP/dtmax with pacing compared to intrinsic rhythm, measured during pacing programming protcol at device implant
measure: Change in exercise capacity by 6MWT distance
timeFrame: Pre-implant, 3 and 6 months post randomization
measure: Change in NYHA functional class
timeFrame: Pre-implant, 3 and 6 months post randomization
Other outcomes:
measure: Sub-group outcome: assessment of LV activation timings with ECGi
timeFrame: 1 month post implant
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital, Barts Health NHS Trust
Study officials:
affiliation: Study Chief Investigator
name: Anthony WC Chow, MBBS BSc MD
role: PRINCIPAL_INVESTIGATOR
References: