Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population - Trial NCT03632057
Access comprehensive clinical trial information for NCT03632057 through Pure Global AI's free database. This phase not specified trial is sponsored by Abbott Medical Devices and is currently Active, not recruiting. The study focuses on Ventricular Arrythmia. Target enrollment is 790 participants.
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Study Focus
Sponsor & Location
Abbott Medical Devices
Timeline & Enrollment
N/A
Jun 06, 2018
May 01, 2025
Primary Outcome
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
Summary
This is a prospective, 1:1 randomized, interventional, multicenter and international trial.
 Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and
 Middle East.
 
 The objective of this study is to evaluate and compare the efficacy of the first appropriate
 shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is
 programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus
 the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a
 standard population of subjects with ICD indication.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03632057
Device Trial