ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
Completed · Phase 4
Conditions studied: Tachyarrhythmia
In brief
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 single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.
Key facts
- Study ID
- NCT00231426
- Run by
- Boston Scientific Corporation
- Starts
- 2003-06-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2006-11-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- LDS Hospital — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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