Protocol page 17The 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.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Protocol page 17
To evaluate the feasibility of acute transvenous electrical stimulation of the
phrenic nerves to elicit diaphragm movement in patients undergoing a cardiac
catheterization involving right heart catheterization and/or EP procedures
and/or device implant, as measured by the proportion patients responding.
Secondary outcome
Protocol page 17 and 18
Evaluate the feasibility of acute transvenous electrical stimulation of the
phrenic nerves to elicit inspiration in patients undergoing a cardiac
catheterization involving right heart catheterization and/or EP procedures
and/or device implant, as measured by the proportion patients responding.
Characterize 1) diaphragm movement and if feasible 2) inspiratory response to
changes on stimulation parameters (electrode configuration, amplitude,
frequency, and pulse width).For each of the tested anatomical positions, the
proportion of patients with capture will be plotted as function of the
stimulation parameters (electrode configuration, amplitude, frequency, and
pulse width).
Characterize other potential physiologic changes or side effects associated
with transvenous nerve stimulation. All observed side effects like potential
physiologic changes or side effects associated with transvenous nerve
stimulation such as pain, hiccup, skeletal muscular tremor, nausea, sinus node
activation will be listed, with number of patients in which the effect was
seen. For side effects that appeared frequently, the relation with stimulation
position and parameters will be investigated.
Background summary
Protocol page 14
Approximately 100 million individuals are suffering from moderate-to-severe
obstructive sleep apnea (OSA) worldwide. In addition, there is a significant
overlap between sleep apnea patients and cardiovascular disease; such as heart
failure, atrial fibrillation, and bradycardia
To treat sleep apnea in heart failure patients a possible solution could be the
extension of leads (which are placed with the tip intra-cardially) with
intravenous electrodes.
Study objective
Protocol page 17
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
Protocol page 18
This is a prospective, non*randomized, acute feasibility study.
Intervention
Protocol page 17
Phrenic nerve stimulation
Study burden and risks
Protocol page 47 and 48
The potential risks to a subject participating in this study are believed to be
similar to those encountered during EP procedures, right heart catheterization
procedures, and device implants.
These include, but are not limited to, the following:
* Electrical current leakage
* Infection
* Injury to the heart or major blood vessels due to direct contact of EP
catheter.
* Pain from stimulation of nerves and/or muscles located in the region of the
great veins
* A blood clot in the heart, lung, or veins.
Endepolsdomein 5
Maastricht 6229GW
NL
Endepolsdomein 5
Maastricht 6229GW
NL
Listed location countries
Age
Inclusion criteria
Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures and/or device implant.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01981590 |
| CCMO | NL51098.060.14 |