Characterization of Cardiac Hemodynamics During MultiSite Pacing

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564186
• Other study ID #: 643
• Status: Completed
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

Outcome

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