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Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPs)

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring breathing, heart failure, sleep apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stichting Catharina Ziekenhuis
Karolinska University Hospital, Solna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All enrolled patients

Arm Description

All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT01981590

First Posted

September 20, 2013

Last Updated

February 28, 2020

Sponsor

Medtronic BRC

1. Study Identification

Unique Protocol Identification Number

NCT01981590

Brief Title

Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

Acronym

MAPs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic BRC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

Keywords

breathing, heart failure, sleep apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All enrolled patients

Arm Type

Experimental

Arm Description

All enrolled patients that underwent a scheduled cardiac catheterization involving an atrial fibrillation (AF) ablation procedure as per clinical practice

Intervention Type

Device

Intervention Name(s)

Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.

Intervention Description

Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.

Primary Outcome Measure Information:

Title

Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)

Description

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

Secondary Outcome Measure Information:

Title

Number of Patients With Response to Stimulation (Tidal Volume)

Description

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

Title

Number of Patients With Observed Side Effects

Description

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

Title

Number of Observed Side Effects

Description

Time Frame

From procedure to 2-4 weeks post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frieder Braunschweig, MD, PhD

Organizational Affiliation

Karolinska Institute, department of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stichting Catharina Ziekenhuis

City

Eindhoven

State/Province

ZIP/Postal Code

5623

Country

Netherlands

Facility Name

Karolinska University Hospital, Solna

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

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