Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

Not Applicable

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
All enrolled patients	Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.	All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice

Primary Outcome Measures

Name	Time	Method
Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)	one hour	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Response to Stimulation (Tidal Volume)	one hour	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
Number of Patients With Observed Side Effects	From procedure to 2-4 weeks post-procedure	Number of patients with observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation
Number of Observed Side Effects	From procedure to 2-4 weeks post-procedure	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