Status:
COMPLETED
ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Tachyarrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a s...
Eligibility Criteria
Inclusion
- Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices
- Patients who sign and date a Patient Informed Consent form prior to the implant visit
- Patients who remain in the clinical care of the enrolling physician in approved centers
- Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex
- Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV
Exclusion
- Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies
- Patients who undergo lead repositioning
- Patients who are expected to receive a heart transplant during the duration of the study
- Patients who have or who are likely to receive a tricuspid valve prosthesis
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
- Patients who are younger than 18 years of age
- Patients who are pregnant or plan to become pregnant during the study
- Patients whose life expectancy is less than 12 months
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00231426
Start Date
June 1 2003
End Date
November 1 2005
Last Update
November 22 2006
Active Locations (1)
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1
LDS Hospital
Salt Lake City, Utah, United States