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Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPs)

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ClinicalTrials.gov Identifier: NCT01981590
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

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 EP catheter advanced into the great veins.

Condition or disease Intervention/treatment Phase
Sleep Apnea Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator. Not Applicable

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  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)
Study Start Date : August 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: phrenic nerve stimulation
intravenously stimulating the phrenic nerve
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.



Primary Outcome Measures :
  1. tidal volume [ Time Frame: one hour ]

    To evaluate the feasibility of transvenous electrical stimulation of the phrenic nerves to elicit inspiration.

    In more detail •Characterize inspiratory response to changes on stimulation parameters (electrode configuration, amplitude, frequency, and pulse width).

    •Characterize other potential physiologic changes or side effects associated with transvenous nerve stimulation.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981590


Locations
Netherlands
Stichting Catharina Ziekenhuis
Eindhoven, EJ, Netherlands, 5623
Sweden
Karolinska University Hospital, Solna
Stockholm, Sweden, 17176
Sponsors and Collaborators
Medtronic BRC
Investigators
Principal Investigator: Frieder Braunschweig, MD, PhD Karolinska Institute, department of Cardiology

Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT01981590     History of Changes
Other Study ID Numbers: MAPs-breathing
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: August 2015

Keywords provided by Medtronic BRC:
breathing, heart failure, sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases