Multisite Pacing With a Quadripolar Lead

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. Identifier: NCT00964938
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : March 27, 2012
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Device: Quadripolar LV lead (pacing configurations) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients
Study Start Date : August 2009
Actual Primary Completion Date : April 2011

Intervention Details:
    Device: Quadripolar LV lead (pacing configurations)
    Quadripolar LV lead will be used to deliver a combination of pacing configurations

Primary Outcome Measures :
  1. dP/dt max [ Time Frame: acute: during implant procedure; 1 day ]

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

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

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 identifier (NCT number): NCT00964938

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Jude Medical Identifier: NCT00964938     History of Changes
Other Study ID Numbers: MSLV
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases