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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All enrolled patients | Experimental | All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one hour |
| Number of Patients With Observed Side Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frieder Braunschweig, MD, PhD | Karolinska Institute, department of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stichting Catharina Ziekenhuis | Eindhoven | EJ | 5623 | Netherlands | ||
| Karolinska University Hospital, Solna |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure | Posted | Count of Participants | Participants | one hour |
|
From procedure to 2-4 weeks post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lilian Kornet, Prin.Scientist | Medtronic Bakken Research Center | +31433566710 | lilian.kornet@medtronic.com |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D053120 | Respiratory Aspiration |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
Number of patients with observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation |
| 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 | From procedure to 2-4 weeks post-procedure |
| Stockholm |
| 17176 |
| Sweden |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| 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 | All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure | Posted | Count of Participants | Participants | one hour |
|
|
|
| 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 | All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure | Posted | Count of Participants | Participants | From procedure to 2-4 weeks post-procedure |
|
|
|
| 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 | All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure | Posted | Number | Side Effect | From procedure to 2-4 weeks post-procedure |
|
|
|
| 0 |
| 15 |
| 3 |
| 15 |
| 4 |
| 15 |
| Sinus node dysfunction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |