Trials / Terminated
TerminatedNCT05055921
MultiPulse Therapy (MPT) for AF (US)
A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation (US)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Multi Pulse Therapy as delivered from the Cardialen External Stimulation System | 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. Other Names: * Unpinning Termination Therapy * Multi-stage therapy * Multi-stage electrotherapy * MultiPulse Therapy |
Timeline
- Start date
- 2022-02-28
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
- First posted
- 2021-09-24
- Last updated
- 2022-10-10
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05055921. Inclusion in this directory is not an endorsement.