NCT03632057

Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population

Shock Efficacy, a Randomized Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 779 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ventricular Arrythmia

Interventions

Type	Name	Description
DEVICE	Fixed Tilt (65%)	This is the standard group, so device programming for shock energy is the default setting
DEVICE	Fixed Pulse Width	The device has to be programmed with fixed pulse width for each phase of the biphasic waveform

Timeline

• Start date: 2018-06-06
• Primary completion: 2025-04-18
• Completion: 2025-04-18
• First posted: 2018-08-15
• Last updated: 2025-05-07

Locations

2 sites across 1 country: Spain