Simultaneous or Sequential Multipoint Pacing

Study Overview
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Brief Summary
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The purpose of this study is to compare electrical acute changes between simultaneous and sequential LV pacing and to assess the paced QRSd over a range of inter- and intra-ventricular programmable delays setting during MPP pacing.

Detailed Description
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The study will be a prospective, single-arm, non-randomized, non-blinded, acute study conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be implanted with a Quadripolar Pacing System who provide informed consent will undergo Enrollment and participate in SCOPE-CRT study. Enrollment and device implant can occur in the same day. Including Enrollment, each subject's participation is expected to be 1-2 days. The total duration of the study is expected to be 12 months, including Enrollment. Enrollment will include the Informed Consent process, physical examination, and collection of demographics, cardiovascular history, medical history, and medications. During CRT implant, surface ECG and PV loop recordings will be taken over the different programmable MPP settings. Following data collection, CRT device programming will be left to the discretion of the physician.

Official Title
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Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy

Conditions
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Cardiac Resynchronization Therapy

Intervention / Treatment
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* Device: CRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA) QRS duration > 130 ms Ability to provide informed consent for study participation At least 18 years of age Exclusion Criteria: Myocardial infarction within 40 days before enrolment NYHA Class IV Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries VT with few or without clinically relevant symptoms VT or VF treatable by surgery Concomitant diseases that would substantially limit a positive prognosis Accelerated intrinsic rhythm Women who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CRT|Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute QRS duration changes during multipoint CRT | Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing. | 1 day during CRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute ECG QRS duration changes during multipoint CRT | Quantify acute changes in surface ECG QRSd over a range of inter- and intra-ventricular programmable delays setting during multipoint CRT pacing. • | 1 day during CRT | 
| Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT | Quantify acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT pacing over a range of inter- and intra-ventricular programmable delays settings. | 1 day during CRT |