Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

Study Overview
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Brief Summary
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The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.

Detailed Description
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Purpose The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter advanced into the great veins. Study Design This is a prospective, non-randomized, acute feasibility study.

Official Title
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Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)

Conditions
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Sleep Apnea

Intervention / Treatment
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* Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects older than 18 years of age Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures and/or device implant. Subjects willing and able to give informed consent Exclusion Criteria: Subject with a previously implanted transvenous lead, which is still present in the veins under study. Subject with evidence of phrenic nerve palsy. Subject with chronic obstructive pulmonary disease. Subject with a spinal cord stimulator. Subject needs to receive drugs that might interfere with patient perception. Subjects with medical conditions that would prevent study participation Subjects who are pregnant, nursing, or of child bearing potential and are not on a reliable form of birth control Subjects enrolled in concurrent studies which could confound the results of this study Subject is unable or unwilling to participate with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All enrolled patients<br>All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice | Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.<br>* Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved) | Number of Patients With Response to Stimulation, defined by Presence of Movement of the Diaphragm Induced by a Pacing Stimulus With Pulse Amplitude of 10 V or Less | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Response to Stimulation (Tidal Volume) | Number of Patients With Response to Stimulation, defined by measured tidal volume of 200 ml or more induced by a pacing stimulus with pulse amplitude of 4 V or less | one hour | 
| Number of Patients With Observed Side Effects | Number of patients with observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation | From procedure to 2-4 weeks post-procedure | 
| Number of Observed Side Effects | All observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation such as pain, hiccup, skeletal muscular tremor, nausea, and sinus node activation | From procedure to 2-4 weeks post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breathing, heart failure, sleep apnea