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
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: 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 September 11, 2014