N/A
N=15
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01981590 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved) — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic BRC
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved) |
15 | — |
| SECONDARY Number of Patients With Response to Stimulation (Tidal Volume) |
9 | — |
| SECONDARY Number of Patients With Observed Side Effects |
6 | — |
| SECONDARY Number of Observed Side Effects |
7 | — |
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 electrophysiology (EP) catheter advanced into the great veins.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01981590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.