Ventricular Tachycardia Clinical Trial
— LEARNOfficial title:
Left Ventricular Capture Management (LEARN) Study
Verified date | April 2018 |
Source | Medtronic Cardiac Rhythm and Heart Failure |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | December 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Center | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm and Heart Failure |
Canada,
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03453645 -
Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
|
||
Completed |
NCT05970120 -
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
|
N/A | |
Completed |
NCT05791032 -
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
|
N/A | |
Completed |
NCT04011631 -
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
|
N/A | |
Recruiting |
NCT03536052 -
Ablation at Virtual-hEart pRedicted Targets for VT
|
N/A | |
Not yet recruiting |
NCT06063811 -
Ventricular Tachycardia Ablation in LVAD Patients
|
||
Enrolling by invitation |
NCT02962076 -
Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia
|
Early Phase 1 | |
Not yet recruiting |
NCT02784912 -
Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation
|
N/A | |
Completed |
NCT01791543 -
Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
|
N/A | |
Terminated |
NCT02891863 -
Low Energy Therapy to Convert Ventricular Tachycardias
|
Phase 0 | |
Terminated |
NCT01546207 -
Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
|
N/A | |
Completed |
NCT01294267 -
Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
|
N/A | |
Terminated |
NCT00383799 -
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
|
Phase 4 | |
Completed |
NCT04884100 -
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
|
N/A | |
Completed |
NCT04642963 -
Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
|
N/A | |
Recruiting |
NCT05377216 -
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation
|
Early Phase 1 | |
Not yet recruiting |
NCT04990089 -
VIVO European Observational Registry
|
||
Completed |
NCT04065893 -
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
|
||
Recruiting |
NCT03631303 -
Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
|
||
Recruiting |
NCT03611465 -
Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts
|
N/A |