Status:
COMPLETED
Feature Assessment Study for Indications Based Programming
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Guidant Corporation
Conditions:
Ventricular Tachycardia
Ventricular Flutter
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indicatio...
Detailed Description
"This study will focus on documenting the final parameter changes that are made in comparison to the IBP recommendations for a specific cardiovascular and arrhythmia history. It will therefore compare...
Eligibility Criteria
Inclusion
- indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines
- Implanted or intended to be implanted with any CE-marked device approved for implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family during first implant (no replacements)
- Geographically stable patients who are available for follow-up at a study centre
- Age 18 or above, or of legal age to give informed consent specific to national law
Exclusion
- Inability or refusal to sign the Patient Informed Consent
- Pregnant or planning to become pregnant
- Replacement device
- Enrolment in another clinical trial, study or evaluation
- Estimated life expectancy of less than six months per discretion of physician
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00711893
Start Date
June 1 2008
End Date
February 1 2010
Last Update
February 23 2017
Active Locations (28)
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1
KH der Elisabethinen Linz
Linz, Austria, 4010
2
KH der Barmherzigen Schwestern Ried/Innkreis
Ried, Austria, 4910
3
Hartcentrum Hasselt - Dienst Cardiologie
Hasselt, Belgium, 3500
4
Prince of Wales Hospital
Hong Kong, Hong Kong, China