|
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: |
NCT00680550 |
|
Date of registration:
|
15/05/2008 |
|
Primary sponsor: |
|
|
Public title:
|
INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT
|
|
Scientific title:
|
Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT. |
|
Date of first enrolment:
|
April 2008 |
|
Target sample size:
|
800 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00680550 |
|
Study type:
|
Observational |
|
Study design:
|
Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
Austria
|
Belarus
|
Czech Republic
|
Finland
|
Germany
|
Italy
|
Netherlands
|
Portugal
|
|
Russian Federation
|
Slovakia
|
Slovenia
|
Spain
|
Sweden
|
Switzerland
|
United Arab Emirates
|
United Kingdom
|
|
Contacts
|
|
Name:
|
Guido Rieger, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medtronic Bakken Research Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patient implanted or scheduled for an implant with a Reveal XT Insertable Cardiac
Monitor System for arrhythmia diagnosis or monitoring
- Patient must be willing to sign a Patient Data Release Form (or Informed Consent
where applicable)
Exclusion Criteria:
- Enrollment outside a 30-day window from the planned/performed Reveal XT implant
procedure (from 15 days pre-implant until 15 days post implant)
- Patient is implanted with a pacemaker, ICD, CRT-device or an implantable hemodynamic
monitoring system
- Unwillingness or inability to cooperate or give written informed consent or, if the
patient is a minor and the legal guardian refuses to give consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Atrial Fibrillation
|
|
Risk of Cardiac Arrhythmias
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|