Status:
COMPLETED
CRT RENEWAL Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decomp...
Detailed Description
The CRT RENEWAL Registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalizati...
Eligibility Criteria
Inclusion
- Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices
- Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads
- Patients who have had an ejection fraction measured within six months of enrollment
- Patients who sign and date a Patient Informed Consent form at the enrollment visit
- Patients who remain in the clinical care of the enrolling physician in approved centers
Exclusion
- Patients who are expected to receive a heart transplant during the duration of the registry
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility
- Patients who are younger than 18 years of age
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry
- Patients who are pregnant
Key Trial Info
Start Date :
May 1 2004
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00146874
Start Date
May 1 2004
Last Update
August 18 2010
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