|
Main
|
|
Note: This record shows only 22 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:
|
19 February 2015 |
|
Main ID: |
NCT01170624 |
|
Date of registration:
|
16/06/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
TUTOR |
|
Scientific title:
|
Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function |
|
Date of first enrolment:
|
September 2009 |
|
Target sample size:
|
388 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT01170624 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Belgium
|
France
|
Germany
|
Italy
|
Portugal
| | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Patient eligible for implantation of an ICD or a CRT-D device according to current
available guidelines.
2. Documented chronic HF (NYHA Class II to IV) at the time of enrollment
3. Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
4. Signed and dated informed consent
Exclusion Criteria:
1. Any contraindication for ICD therapy
2. Abdominal implantation site
3. Acute myocarditis
4. Unstable coronary symptoms (unstable angina or myocardial infarction) within the last
month
5. Planned heart transplant
6. Mechanical tricuspid valve
7. Unable to perform the 6 minute Walking Test at time of enrollment
8. Already included in another clinical study
9. Life expectancy less than 13 months
10. Inability to understand the purpose of the study or refusal to cooperate
11. Inability or refusal to provide informed consent
12. Under guardianship
13. Age of less than 18 years
14. Pregnancy (Women of childbearing potential should have a negative pregnancy test
prior to enrollment)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Failure
|
|
Intervention(s)
|
|
Device: ICD
|
|
Primary Outcome(s)
|
|
The objective is to demonstrate that agreement correlation is superior to 67%
[Time Frame: 13 months]
|
|
Secondary ID(s)
|
|
TUTOR - ITSY04
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|