Heart Failure, Left Bundle-Branch Block, Systolic Dysfunction
Conditions
Keywords
Cardiac Resynchronization Therapy, MultiSite Pacing
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.
Interventions
DEVICEOptimised 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.
Conventional programming settings using biventricular pacing will be used
Sponsors
Boston Scientific Corporation
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Single-center, prospective, two-arm, randomized 1:1, crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic clinical response | 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
| Measure | Time frame | Description |
|---|---|---|
| Acute changes in surface ECG QRS duration and morphology | 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 | 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 | Pre-implant, 3 and 6 months post randomization | 6 minute walk test distance |
| Change in NYHA functional class | Pre-implant, 3 and 6 months post randomization | New York Heart Association Functional class |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sub-group outcome: assessment of LV activation timings with ECGi | 1 month post implant | Electrocardiographic imaging |
Countries
United Kingdom
Outcome results
None listed