Status:
COMPLETED
Cologne Cardioversion Study
Lead Sponsor:
Universitätsklinikum Köln
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Arrhythmia
Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Implantation of internal defibrillators, capable of monitoring the heart and shocking life threatening arrhythmias back to normal rhythm, for patients with severe heart failure increases the probabili...
Detailed Description
Introduction A mortality benefit of implanted cardiac defibrillators in patients (pts) with severely impaired LV function has been established in multiple large trials. Atrial fibrillation, -flutter a...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Informed, written consent
- Atrial arrhythmia with indication for CV
- Status post ICD implantation, including CRT-D
Exclusion
- Age \< 18 years
- Patients under guardianship or with mental disorders / disabilities
- ICD implantation \< 4 weeks prior to CV
- ICD lead implantation \< 4 weeks prior to CV
- Battery in EOL, ERM or ERI, ERT
- Indications of compromised leads (Impedance \<200 or \>2000 Ohm, Pacing threshold \>5V/0.4ms), RV Sensing \<4mV or RA sensing \<0,1mV)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2018
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT02241382
Start Date
September 1 2014
End Date
January 24 2018
Last Update
January 26 2018
Active Locations (13)
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1
Royal Adelaide Hospital
Adelaide, Australia
2
University Hospital Lübeck
Lübeck, Schleswig-Holstein, Germany
3
University Hospital Aachen
Aachen, Germany
4
Heart & Diabetes Center NRW
Bad Oeynhausen, Germany, 32545