MPP Programming Study

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Procedure: Hemodynamic measurements for CRT device programming; Device: CRT device implant with MultiPoint Pacing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01856725

CRD_684

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved standard indication by ESC/EHRA Guidelines
• Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion criteria

• Have high ventricular rate (>90 bpm) during persistent or permanent atrial fibrillation despite available treatment
• Be in NYHA IV functional class
• Have a recent myocardial infarction within 40 days prior to enrollment
• Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
• Have had a recent CVA or TIA within 3 months prior to enrollment
• Have had intravenous inotropic support in the last 30 days
• Be less than 18 years of age
• Be pregnant or planning to become pregnant during the duration of the investigation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

MultiPoint Pacing programming based on hemodynamics

Active Comparator group

Description:

CRT device implant with MultiPoint Pacing Hemodynamic measurements for CRT device programming

Treatment:

Device: CRT device implant with MultiPoint Pacing

Procedure: Hemodynamic measurements for CRT device programming

MultiPoint Pacing programming without hemodynamics

Experimental group

Description:

CRT device implant with MultiPoint Pacing CRT device programming without hemodynamics

Treatment:

Device: CRT device implant with MultiPoint Pacing