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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.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01044784
First received: January 6, 2010
Last updated: March 24, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
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
  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 indications.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044784

Locations
Germany
Schuchtermannklinik
Bad Rothenfelde, Germany
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude MedicaL, Clinical Studies
ClinicalTrials.gov Identifier: NCT01044784     History of Changes
Other Study ID Numbers: 60028011
Study First Received: January 6, 2010
Last Updated: March 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
CRT

ClinicalTrials.gov processed this record on June 18, 2013