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Dependence of LV Hemodynamics on Pacing Site

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01564173
First received: March 24, 2012
Last updated: October 13, 2014
Last verified: October 2014

March 24, 2012
October 13, 2014
June 2012
May 2015   (final data collection date for primary outcome measure)
Invasive Dp/dt Max [ Time Frame: Acute E.P. Procedure ] [ Designated as safety issue: No ]
Variation on invasive Dp/dt max during dedicated pacing site
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Complete list of historical versions of study NCT01564173 on ClinicalTrials.gov Archive Site
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Dependence of LV Hemodynamics on Pacing Site
Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing

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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach

Heart Failure
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VT Ablation
Patients undergoing epicardial mapping and ablation procedure for a ventricular tachycardia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
France
 
NCT01564173
644
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Pierre Jais, MD University Hospital, Bordeaux
St. Jude Medical
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP