Left Ventricular Capture Management Study

NCT01089634 | Completed

• 1 other identifier: LEARN2007
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Fibrillation; Ventricular Tachycardia; Bradyarrhythmia

Keywords

LV measurement; CRT; Concerto; LVCM; LV threshold; new CRT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular; Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Mary McCann, R.N., MBA

  Medtronic

  STUDY CHAIR

• Allison Rubino

  Medtronic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: October 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

CA (1)