Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPs)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • EJ
    • Eindhoven, EJ, Netherlands, 5623
      • Stichting Catharina Ziekenhuis
• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital, Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All enrolled patients; 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.; Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Principal Investigator: Frieder Braunschweig, MD, PhD, Karolinska Institute, department of Cardiology

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: breathing, heart failure, sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: MAPs-breathing