Status:
COMPLETED
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
Lead Sponsor:
Abbott Medical Devices
Conditions:
Postoperative Cardiac Complication
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (...
Eligibility Criteria
Inclusion
- Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
- Patients age is 18 years or greater
- Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
- Patients must be willing and able to comply with all study requirements
Exclusion
- Patients with a life expectancy \<12 months.
- Patients who are or may potentially be pregnant.
- Patient has suffered any of the following in the 4 weeks prior to enrolment:
- Myocardial Infarction (MI)
- Coronary Artery Bypass Graft (CABG)
- Unstable Angina Pectoris
- Patient has primary valvular disease which has not been corrected
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
1078 Patients enrolled
Trial Details
Trial ID
NCT01510652
Start Date
November 1 2011
End Date
May 1 2014
Last Update
February 15 2019
Active Locations (64)
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1
Ziekenhuis Oost-Limburg
Genk, Belgium
2
Hopital La Citadelle
Liège, Belgium
3
Foothills Medical Center
Calgary, Canada
4
Royal Alexandra Hospital
Edmonton, Canada