An interventional study of MultiPulse Therapy in Atrial Fibrillation, sponsored by Cardialen, Inc.. Terminated at 2 sites in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by Cardialen, Inc. · Not applicable, Interventional, and Other
Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.
A prospective non-randomized feasibility study involving acute testing of MPT in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure). The primary outcome of the study is the subject response to questions regarding perception and acceptability following MPT delivery.
3,958 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 6 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Cardialen, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Study stage dependent: Stage 1:
6a. History of DC-Cardioversion in past 12 months: With or Without
7b. AFEQT Score: \<=89
Study stage dependent: Stage 2 (based on results from study stage 1):
6a: History of DC-Cardioversion in past 12 months: Potential emphasis on patients with history of DCCV
7b. AFEQT Score: Potential emphasis on patients with AFEQT \<= 58
Exclusion Criteria:
The study will be conducted using the venous cannulations that are standard of care for the indicated procedure. Additional access points may be necessary if access to coronary sinus is difficult from existing femoral venous cannulations. Sterile study leads or EP catheters will be temporarily placed into the RA, CS, and RV (for R-wave sensing using intracardiac electrograms - optional) which will be connected to the investigational device (CESS). Up to two MPTs will be delivered and subject responses following each MPT regarding perception and acceptability of MPT to treat AF will be obtained. MPT voltages will not exceed 100V.
Device: MultiPulse Therapy
Electrical Stimulation
Therapy acceptance as measured by a subject question administered immediately following MPT delivery
Question: "Now I want you to think about your experiences with Atrial Fibrillation. Think about how it makes you feel, your daily life while in atrial fibrillation and your experience with in-clinic treatments for atrial fibrillation. If you could use the stimulation you just felt at home and under your control, would you use this stimulation therapy to stop your atrial fibrillation? Please answer yes or no."
Time frame: Immediately following MPT delivery
Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
Question: "Please rate any pain you experienced at the time of the stimulus, was it: No pain, mild pain, moderate pain, severe pain, the worst possible pain imaginable."?
Time frame: Immediately following MPT delivery
Safety determined from summary report of Adverse Events
Adverse Event frequency by Adverse Event type
Time frame: Through 30 days post-intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2021 to primary completion in Oct 2022, 10 months.
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This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Cardialen, Inc.