Left Ventricular Capture Management Study (LEARN)

This study has been completed.
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT01089634
First received: March 17, 2010
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

Primary Objective:

To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements.

Study Design:

This is a multicenter, prospective, non-interventional study with patients receiving their first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD) device. The study design, based on the primary objective, is an observational examination of LV thresholds over time. Daily left ventricular threshold measurements will be collected using the LVCM feature. Up to 150 patients will be enrolled in Canada to evaluate the primary objective at up to 15 study centers.

Data will be collected at Baseline, Implant, 12 months post-implant and all regularly scheduled follow-up visits up to 12 months post-implant.

Devices:

The ConcertoTM CRT-ICD device and future Medtronic CRT-ICD devices containing the LVCM feature will be used in this study.


Condition
Ventricular Fibrillation
Ventricular Tachycardia
Bradyarrhythmia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Left Ventricular Capture Management (LEARN) Study

Resource links provided by NLM:


Further study details as provided by Medtronic:

Enrollment: 151
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Patients who will be implanted with their first CRT defibrillator system.
  • Patients who will be implanted with a Medtronic CRT defibrillator containing the LVCM feature.
  • Patients who are willing and able to sign an IRB/MEC approved patient informed consent.
  • Patients who are geographically stable and available for follow-up at the study center for the required follow-up duration of the study
Criteria

Inclusion Criteria:

  • Patients who will be implanted with their first CRT defibrillator system.
  • Patients who will be implanted with a Medtronic CRT defibrillator containing the LVCM feature.
  • Patients who are willing and able to sign an IRB/MEC approved patient informed consent.
  • Patients who are geographically stable and available for follow-up at the study center for the required follow-up duration of the study

Exclusion Criteria:

  • Patients who have a pre-existing LV lead prior to enrollment
  • Patients who have a life expectancy of less than 1 year
  • Patients included in another clinical trial that will affect the objectives of this study
  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: NCT01089634

Locations
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Medtronic
Investigators
Study Chair: Mary McCann, R.N., MBA Medtronic
Study Chair: Allison Rubino Medtronic
  More Information

No publications provided

Responsible Party: Clinical Research Specialist, Medtronic of Canada
ClinicalTrials.gov Identifier: NCT01089634     History of Changes
Other Study ID Numbers: LEARN2007
Study First Received: March 17, 2010
Last Updated: March 25, 2011
Health Authority: Canada: Health Canada

Keywords provided by Medtronic:
LV measurement
CRT
Concerto
LVCM
LV threshold
new CRT

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014