MultiPoint Pacing Mapping Study

Terminated

• Conditions: Heart Failure

• Registration Number: NCT02547207
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Study Start: 2015-12
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Be scheduled to undergo or have received within the past 30 days an implant of a SJM (St. Jude Medical) MPP CRT-D system with approved standard indication by ESC (European Society of Cardiology) / EHRA (European Heart Rhythm Association) 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
• Be in sinus rhythm

Exclusion Criteria

• Complete AV (atrioventricular) block
• Permanent atrial fibrillation
• Have a recent myocardial infarction within 40 days prior to enrollment
• Have undergone cardiac 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 (cerebrovascular accident) or TIA (transient ischemic attack) 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 plan to become pregnant over the next 7 months
• Have significant peripheral vascular disease
• Have LV thrombus
• Significant aortic valve disease or replacement
• Mitral valvular disease
• Contraindicated for Gadolinium contrast agent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings	up to 30 days post-implant

Trial Locations

Locations (4)

Herzzentrum Dresden Universitätsklinik; 🇩🇪 Dresden, Germany

St. Thomas Hospital; 🇬🇧 London, United Kingdom

CHU Pontchaillou; 🇫🇷 Rennes, France

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany