Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPs)

Medtronic

Status: Completed

Conditions: Sleep Apnea

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01981590

MAPs-breathing

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

All enrolled patients

Experimental group

Description:

All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice

Treatment:

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