Dependence of LV Hemodynamics on Pacing Site

Completed

• Conditions: Heart Failure

• Registration Number: NCT01564173
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the LV.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-24
• Study First Submitted QC: 2012-03-24
• Study First Posted: 2012-03-27
• Study Start: 2012-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Patient is already indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
• Be in sinus rhythm
• Have LVEF < 40%
• Have the ability to provide informed consent for study participation and be willing and able to comply with the CIP (Clinical Investigational Plan) described evaluations

Exclusion Criteria

• Have permanent AF
• Have pericardial disease
• 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
• Have had a recent CVA or TIA within 3 months prior to enrollment
• Be less than 18 years of age
• Be pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Invasive Dp/dt Max	Acute E.P. Procedure	Variation on invasive Dp/dt max during dedicated pacing site

Trial Locations

Locations (1)

CHU; 🇫🇷 Bordeaux, France