Sleep Apnea
Conditions
Keywords
breathing, heart failure, sleep apnea
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 electrophysiology (EP) catheter advanced into the great veins.
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.
Interventions
DEVICEStimulating 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.
Sponsors
Medtronic BRC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Response to Stimulation (Tidal Volume) | 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 |
| Number of Patients With Observed Side Effects | 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 |
| Number of Observed Side Effects | 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 |
Countries
Netherlands, Sweden
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Phrenic Nerve Stimulation Intravenously stimulating the phrenic nerve
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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Phrenic Nerve Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 8 |
| Region of Enrollment Netherlands | 8 participants |
| Region of Enrollment Sweden | 7 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 4 / 15 |
| serious Total, serious adverse events | 3 / 15 |
Outcome results
Primary
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
Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Phrenic Nerve Stimulation Achieved | Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved) | 15 Participants |
Secondary
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
Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Phrenic Nerve Stimulation Achieved | Number of Observed Side Effects | 7 Side Effect |
Secondary
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
Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Phrenic Nerve Stimulation Achieved | Number of Patients With Observed Side Effects | 6 Participants |
Secondary
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
Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Phrenic Nerve Stimulation Achieved | Number of Patients With Response to Stimulation (Tidal Volume) | 9 Participants |