An interventional study of Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator. in Sleep Apnea, sponsored by Medtronic BRC. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-16.
Sponsored by Medtronic BRC (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
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.
2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.
This study's enrollment of 15 is below the median of 53 across 1,400 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Medtronic BRC is the lead sponsor of 26 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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
Time frame: one hour
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
Time frame: 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
Time frame: 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
Time frame: From procedure to 2-4 weeks post-procedure
15 subjects have been enrolled, in Sweden (Karolinska University Hospital, Solna in Stockholm) and in The Netherlands (Catherina Hospital in Eindhoven). All the 15 subjects enrolled underwent the study procedure and performed the 2-4 weeks post-procedure assessment follow-up
| Milestone | Phrenic Nerve Stimulation |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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
| Participants | Patients With Phrenic Nerve Stimulation Achieved |
|---|---|
| Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved) | 15 |
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
| Participants | Patients With Phrenic Nerve Stimulation Achieved |
|---|---|
| Number of Patients With Response to Stimulation (Tidal Volume) | 9 |
Number of patients with observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation
| Participants | Patients With Observed Side Effects |
|---|---|
| Number of Patients With Observed Side Effects | 6 |
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
| Side Effect | Patients With Observed Side Effects |
|---|---|
| Number of Observed Side Effects | 7 |
Collected over From procedure to 2-4 weeks post-procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phrenic Nerve Stimulation | 0/15 (0%) | 3/15 (20%) | 4/15 (26.7%) |
| Event | Phrenic Nerve Stimulation |
|---|---|
| Atrial fibrillationCardiac disorders | 1/15 |
| Sinus node dysfunctionCardiac disorders | 1/15 |
| Peripheral artery aneurysmVascular disorders | 1/15 |
| Event | Phrenic Nerve Stimulation |
|---|---|
| Atrial fibrillationCardiac disorders | 2/15 |
| Supraventricular tachycardiaCardiac disorders | 1/15 |
| Sinus node dysfunctionCardiac disorders | 1/15 |
| Age, Categorical(Participants) | Phrenic Nerve Stimulation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 5 |
| Age, Continuous(years) | Phrenic Nerve Stimulation |
|---|---|
| Mean | 60 ± 8 |
| Sex: Female, Male(Participants) | Phrenic Nerve Stimulation |
|---|---|
| Female | 6 |
| Male | 9 |
| Region of Enrollment(participants) | Phrenic Nerve Stimulation |
|---|---|
| Sweden | 7 |
| Netherlands | 8 |
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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