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Characterization of Cardiac Hemodynamics During MultiSite Pacing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01564186
First Posted: March 27, 2012
Last Update Posted: April 9, 2014
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.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class assessment and echocardiographic measurements are performed at 3 months and 12 months post-implant to characterize long-term effect of MPP.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of Cardiac Hemodynamics by Pressure-Volume Loop Analysis During MultiPoint Pacing

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Within-patient differences in PV loop-based hemodynamic parameters (dP/dtMax, stroke work, stroke volume, ejection fraction) [ Time Frame: At implant ]

Enrollment: 44
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
MulitPoint Pacing
BiV Conventional

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for standard CRT-D therapy.
Criteria

Inclusion Criteria:

  • Be scheduled to undergo implant of a St Jude Medical CRT-D system with approved standard indication by ESC/EHRA Guidelines
  • Be in sinus rhythm at the time of enrollment
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria:

  • Exhibit Cheyne-Stokes respiration
  • Have persistent or permanent atrial fibrillation
  • Have complete heart block
  • Be in NYHA IV functional class
  • 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 in the following 7 months
  • Have had a recent CVA or TIA within 3 months prior to enrollment
  • Have had intravenous inotropic support in the last 30 days
  • Be less than 18 years of age
  • Be pregnant
  Contacts and Locations
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): NCT01564186


Locations
Italy
Maria Cecilia Hospital
Cotignola, Italy, 48010
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Carlo Pappone, MD Maria Cecilia Hospital