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Dependence of LV Hemodynamics on Pacing Site

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01564173
First received: March 24, 2012
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
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
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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


Enrollment: 13
Study Start Date: June 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
VT Ablation
Patients undergoing epicardial mapping and ablation procedure for a ventricular tachycardia

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564173

Locations
France
CHU
Bordeaux, France
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Pierre Jais, MD University Hospital, Bordeaux
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01564173     History of Changes
Other Study ID Numbers: 644 
Study First Received: March 24, 2012
Last Updated: March 23, 2016
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2016