Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead (MSLV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01044472
First received: January 7, 2010
Last updated: April 13, 2016
Last verified: April 2016
  Purpose
The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.

Condition
Multi-site Left Ventricular Pacing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead

Further study details as provided by St. Jude Medical:

Enrollment: 61
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Detailed Description:
To evaluate the hemodynamic impact of different pacing MSLV configurations.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with standard CRT-D indications
Criteria

Inclusion Criteria:

  • Patients who have a recognised indication to receive a CRT-D device or an upgrade from a pacemaker or ICD to a CRT-D system.
  • Patients have signed an informed consent form indicating their willingness to participate to this study.

Exclusion Criteria:

  • Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
  • Patients with second or third degree AV Block
  • Patients with intrinsic atrial rhythm < 40 bpm
  • Patients with a previously implanted left ventricular pacing lead.
  • Patients who are pregnant.
  • Patients currently participating in a clinical investigation that includes an active treatment arm.
  • Patients under 18 years of age.
  • Patients with a life expectancy of less then 6 months.
  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: NCT01044472

Locations
Germany
Herzzentrum
Bad Krozingen, Germany
Kerckhoff - Klinik
Bad Nauheim, Germany
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, Germany
Schüchtermannklinik
Bad Rothenfelde, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, Germany
Städt. Klinikum
Ludwigshafen, Germany
Klinikum Rosenheim
Rosenheim, Germany
United Kingdom
Russells Hall
Dudley, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
St Thomas
London, United Kingdom
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01044472     History of Changes
Other Study ID Numbers: CR-09-048-EU-HF 
Study First Received: January 7, 2010
Last Updated: April 13, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by St. Jude Medical:
CRT-D

ClinicalTrials.gov processed this record on August 28, 2016