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Dependence of LV Hemodynamics on Pacing Site

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ClinicalTrials.gov Identifier: NCT01564173
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Heart Failure

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing
Study Start Date : June 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Group/Cohort
VT Ablation
Patients undergoing epicardial mapping and ablation procedure for a ventricular tachycardia



Primary Outcome Measures :
  1. Invasive Dp/dt Max [ Time Frame: Acute E.P. Procedure ]
    Variation on invasive Dp/dt max during dedicated pacing site



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564173


Locations
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France
CHU
Bordeaux, France
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Pierre Jais, MD University Hospital, Bordeaux
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01564173    
Other Study ID Numbers: 644
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases