MPP Programming Study

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Hemodynamic measurements for CRT device programming; Device: CRT device implant with MultiPoint Pacing

• Registration Number: NCT01856725
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-17
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MultiPoint Pacing programming based on hemodynamics	Hemodynamic measurements for CRT device programming	CRT device implant with MultiPoint Pacing Hemodynamic measurements for CRT device programming
MultiPoint Pacing programming without hemodynamics	CRT device implant with MultiPoint Pacing	CRT device implant with MultiPoint Pacing CRT device programming without hemodynamics
MultiPoint Pacing programming based on hemodynamics	CRT device implant with MultiPoint Pacing	CRT device implant with MultiPoint Pacing Hemodynamic measurements for CRT device programming

Primary Outcome Measures

Name	Time	Method
end-systolic volume	6 months

Trial Locations

Locations (1)

Maria Cecilia Hospital, GVM Care & Research; 🇮🇹 Cotignola, RA, Italy