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

NCT03632057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 779

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

  • Ventricular Arrythmia

Interventions

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ignacio Fernandez, MD

  • Javier Alzueta, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2025-04-18
Completion
2025-04-18

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632057 on ClinicalTrials.gov