MultiPoint Pacing Mapping Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02547207

Enrollment

Registered

2015-09-11

Start date

2015-12-31

Completion date

2018-10-31

Last updated

2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France, Germany, United Kingdom

Outcome results