NCT04206917

MultiPulse Therapy (MPT) for AF

A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation Energy Therapy in Patients With Atrial Fibrillation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cardialen, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.

Detailed description

A prospective non-randomized feasibility study involving acute testing of MPT in subjects with paroxysmal and persistent AF during clinically indicated atrial fibrillation catheter ablation procedure. Subjects will be split into 2 cohorts depending on status at time of procedure. 1. In Atrial Fibrillation at time of procedure (Clinical AF) 2. In Normal Sinus Rhythm at time of procedure Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.

Conditions

• Atrial Fibrillation, Paroxysmal
• Atrial Fibrillation, Persistent
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Multi Pulse Therapy	The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen MultiPulse Therapy (MPT). The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.

Timeline

• Start date: 2020-03-19
• Primary completion: 2022-06-21
• Completion: 2022-06-21
• First posted: 2019-12-20
• Last updated: 2022-10-14

Locations

6 sites across 1 country: Australia

Regulatory

• FDA-regulated device study