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Completed

NCT Number: NCT01981590

Mapping for Acute Transvenous Phrenic Nerve Stimulation 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.

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Key information

Conditions

Sleep Apnea Apnea Cardiovascular Diseases Dyssomnias Heart Diseases Heart Failure Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Catharina Ziekenhuis, Eindhoven, EJ, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.

Primary outcomes

  1. Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)

    Time frame: 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 outcomes

  1. Number of Patients With Response to Stimulation (Tidal Volume)

    Time frame: 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

  2. Number of Patients With Observed Side Effects

    Time frame: 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

  3. Number of Observed Side Effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medtronic BRC

Industry

Registry information

Official study title

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

Acronym: MAPs

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2013
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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