NCT04132466

ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Kestra Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients

Detailed description

The objective of this study is to evaluate Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) conversion efficacy in adult human subjects using the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform.

Conditions

• Death, Sudden, Cardiac

Interventions

Type	Name	Description
DEVICE	Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system	defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator

Timeline

• Start date: 2019-11-25
• Primary completion: 2020-03-19
• Completion: 2020-03-19
• First posted: 2019-10-18
• Last updated: 2024-04-05
• Results posted: 2024-04-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study