|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00324662 |
|
Date of registration:
|
10/05/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)
|
|
Scientific title:
|
ADRIA - Belos A+ vs DR Clinical Investigation of Arrhythmia Discrimination |
|
Date of first enrolment:
|
August 2003 |
|
Target sample size:
|
260 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00324662 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
|
Germany
|
Switzerland
| | | | | |
|
Contacts
|
|
Name:
|
Michael Niehaus, Prof. Dr. Med. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- ICD indication according to American College of Cardiology/American Heart Association
(ACC/AHA) guidelines.
- Informed consent
Exclusion Criteria:
- Permanent atrial fibrillation
- Requirement for atrial pacing
- Patient is underage
- No signed patient agreement
- Patient life expectancy under 6 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Tachyarrhythmia
|
|
Intervention(s)
|
|
Device: Implantable cardioverter-defibrillator
|
|
Primary Outcome(s)
|
|
Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity)
|
|
Secondary Outcome(s)
|
|
Complication rate (e.g. lead dislocation, lead fracture)
|
|
Duration of implantation
|
|
Electrode performance (P-/R-wave amplitudes, ventricular pacing threshold and impedance)
|
|
Sensitivity (rate of correctly discriminated episodes of ventricular fibrillation or ventricular tachycardia)
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|