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Acute Evaluation of the Safety of Left Ventricular-left Ventricular (LV-LV) Delays and Its Effects on Mechanical Dyssynchrony

This study has been completed.
Information provided by:
St. Jude Medical Identifier:
First received: January 6, 2010
Last updated: March 24, 2012
Last verified: March 2012
The purpose of this study is to evaluate the effects of various LV-LV delays during multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (CRT) patients post-implant.

Cardiac Resynchronization Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Evaluation of the Safety of LV-LV Delays and Its Effects on Mechanical Dyssynchrony

Further study details as provided by St. Jude Medical:

Estimated Enrollment: 50
Study Start Date: February 2010

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 indications.

Inclusion Criteria:

  1. Have an approved indication for a CRT implant
  2. Undergoing or previously received the implant of a St. Jude Medical Promote Q 3221-36 CRT-D with a Quartet Model 1458Q LV lead at participating clinical study site
  3. Ability to provide informed consent for study participation and be willing and able to comply with the prescribed evaluations

Exclusion Criteria:

  1. Have persistent or permanent atrial fibrillation
  2. Have an intrinsic heart rate of <50 beats per minute
  3. Have Cheyne-Stokes breathing
  4. Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
  5. Have had a recent CVA or TIA within 3 months prior to enrollment
  6. Be less than 18 years of age
  7. 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 identifier: NCT01044784

Bad Rothenfelde, Germany
Sponsors and Collaborators
St. Jude Medical