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Dependence of LV Hemodynamics on Pacing Site

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 24, 2012
First Posted Date March 27, 2012
Last Update Posted Date February 4, 2019
Study Start Date June 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 13, 2014)
Invasive Dp/dt Max [ Time Frame: Acute E.P. Procedure ]
Variation on invasive Dp/dt max during dedicated pacing site
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dependence of LV Hemodynamics on Pacing Site
Official Title Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts VT Ablation
Patients undergoing epicardial mapping and ablation procedure for a ventricular tachycardia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2016)
13
Original Estimated Enrollment
 (submitted: March 24, 2012)
40
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01564173
Other Study ID Numbers 644
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Principal Investigator: Pierre Jais, MD University Hospital, Bordeaux
PRS Account Abbott Medical Devices
Verification Date January 2019