NCT00541541

Brief Summary

In this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. Heart function is assessed by acoustic cardiography.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

5.2 years

First QC Date

October 8, 2007

Last Update Submit

April 16, 2013

Conditions

Heart Failure, CongestiveCardiac Pacing, ArtificialTranscutaneous Electric Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing

    One day

Interventions

Phrenic nerve stimulationPROCEDURE

Patients receive a phrenic nerve stimulation

Eligibility Criteria

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

You may qualify if:

  • Patients following open heart surgery who need temporary pacing

You may not qualify if:

  • Patients with permanent pacemakers
  • Patients with fast changing need of vasopressor therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Luzern, Department of Cardiology

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Paul Erne, MD

    Luzerner Kantonsspital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Paul Erne

Study Record Dates

First Submitted

October 8, 2007

First Posted

October 10, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2012

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

CH(1)