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Sponsor ceased operations
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiPulse Therapy | Device | Electrical Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 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."? | Immediately following MPT delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety determined from summary report of Adverse Events | Adverse Event frequency by Adverse Event type | Through 30 days post-intervention |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | Australia | |||
| St. Andrew's Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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A prospective non-randomized feasibility study involving acute evaluation of the perception and acceptance of MPT as a therapy to stop episodes of AF in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure).
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| Adelaide |
| South Australia |
| Australia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |