Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

Sleep Apnea Clinical Trial

— MAPs  

Official title:

Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981590
• Other study ID #: MAPs-breathing
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2020
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Stichting Catharina Ziekenhuis	Eindhoven	EJ
Sweden	Karolinska University Hospital, Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	one hour
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	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	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	From procedure to 2-4 weeks post-procedure