Multisite Pacing With a Quadripolar Lead

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00964938
First received: May 25, 2009
Last updated: March 24, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.


Condition Intervention Phase
Heart Failure
Device: Quadripolar LV lead (pacing configurations)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • dP/dt max [ Time Frame: acute: during implant procedure; 1 day ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: August 2009
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Quadripolar LV lead (pacing configurations)
    Quadripolar LV lead will be used to deliver a combination of pacing configurations
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a scheduled CRT implantation at the participating clinical study site
  • Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
  • Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations

Exclusion Criteria:

  • Have persistent or permanent atrial fibrillation
  • Have an intrinsic heart rate of <50 beats per minute
  • 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
  • Have had intravenous inotropic support in the last 30 days
  • Have ischemic etiology and are unable to tolerate stress echocardiography
  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: NCT00964938

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: B Thibault Montreal Heart
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00964938     History of Changes
Other Study ID Numbers: MSLV
Study First Received: May 25, 2009
Last Updated: March 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Jude Medical:
Hemodynamic response
Cardiac resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014