Characterization of Cardiac Hemodynamics During MultiSite Pacing

Characterization of Cardiac Hemodynamics by Pressure-Volume Loop Analysis During MultiPoint Pacing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01564186

Enrollment

Registered

2012-03-27

Start date

2012-04-30

Completion date

2013-12-31

Last updated

2019-02-04

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 evaluate the effects of MultiPoint Pacing (MPP) on cardiac hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class assessment and echocardiographic measurements are performed at 3 months and 12 months post-implant to characterize long-term effect of MPP.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Be scheduled to undergo implant of a St Jude Medical CRT-D system with approved standard indication by ESC/EHRA Guidelines * Be in sinus rhythm at the time of enrollment * 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

* Exhibit Cheyne-Stokes respiration * Have persistent or permanent atrial fibrillation * Have complete heart block * Be in NYHA IV functional class * 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 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

Design outcomes

Primary

Measure	Time frame
Within-patient differences in PV loop-based hemodynamic parameters (dP/dtMax, stroke work, stroke volume, ejection fraction)	At implant

Countries

Italy

Outcome results