Sleep ApneaMAPsNCT01981590
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
A study testing Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator. in people with Sleep Apnea, run by Medtronic BRC at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)
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.
Read the 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.
- Conditions
- Sleep Apnea
- Being tested
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
- Keywords
- breathing, heart failure, sleep apnea
- Medical subject headings
- Sleep Apnea Syndromes, Respiratory Aspiration, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients | Experimental | All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice Receives: Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one hour
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: From procedure to 2-4 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frieder Braunschweig, MD, PhD, Principal investigator, Karolinska Institute, department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981590
- Sponsor's protocol ID
- MAPs-breathing
- Acronym
- MAPs
- Status last verified
- Feb 2020
- First submitted
- 20 Sep 2013
- Last updated
- 16 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)
- ClinicalTrials.gov ID
- NCT01981590
- Acronym / sponsor ID
- MAPs / MAPs-breathing
- Conditions
- Sleep Apnea
- Keywords
- breathing, heart failure, sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients | Experimental | Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | All enrolled patients |
Primary outcome
Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)
Time frame: 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
3 secondary outcomes
Number of Patients With Response to Stimulation (Tidal Volume)
Time frame: one hour
Number of Patients With Observed Side Effects
Time frame: From procedure to 2-4 weeks post-procedure
Number of Observed Side Effects
Time frame: From procedure to 2-4 weeks post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frieder Braunschweig, MD, PhD principal investigator
Karolinska Institute, department of Cardiology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator. in people with Sleep Apnea, run by Medtronic BRC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved) (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.