Characterization of Cardiac Hemodynamics During MultiSite Pacing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01564186
First received: March 24, 2012
Last updated: April 8, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564186

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01564186     History of Changes
Other Study ID Numbers: 643
Study First Received: March 24, 2012
Last Updated: April 8, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014