NCT01981590

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

September 20, 2013

Results QC Date

December 1, 2017

Last Update Submit

February 28, 2020

Conditions

Sleep Apnea

Keywords

breathing, heart failure, sleep apnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of Patients With Response to Stimulation (Tidal Volume)

    one hour

  • Number of Patients With Observed Side Effects

    From procedure to 2-4 weeks post-procedure

  • Number of Observed Side Effects

    From procedure to 2-4 weeks post-procedure

Study Arms (1)

All enrolled patients

EXPERIMENTAL

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

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

Interventions

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.

All enrolled patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stichting Catharina Ziekenhuis

Eindhoven, EJ, 5623, Netherlands

Location

Karolinska University Hospital, Solna

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesRespiratory AspirationHeart Failure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Lilian Kornet, Prin.Scientist
Organization
Medtronic Bakken Research Center
lilian.kornet@medtronic.com
+31433566710

Study Officials

  • Frieder Braunschweig, MD, PhD

    Karolinska Institute, department of Cardiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

November 11, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 16, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-02

Locations

SE(1)NL(1)