NCT00170261

Brief Summary

This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_4

Geographic Reach
1 country

3 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

April 1, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 3, 2025

Status Verified

April 1, 2018

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

June 30, 2025

Conditions

Syncope

Keywords

Syncope of uncertain etiologyRepeated presyncopes

Outcome Measures

Primary Outcomes (1)

  • Cost of diagnostics per patient until final cardiac diagnosis has been made

Secondary Outcomes (4)

  • Cost of diagnostics until final diagnosis has been made

  • Rate of correct cardiac diagnoses

  • Comparison of time needed to make a diagnosis

  • Comparison of pre-syncopes and syncopes occuring in both groups after enrollment

Interventions

Use of an Implantable Loop RecorderDEVICE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes

You may not qualify if:

  • Indication for the implantation of a pacemaker
  • Indication for the implantation of an implantable cardioverter defibrillator
  • Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular \[LV\] outflow stenosis, decompensated heart failure)
  • Contraindication for a diagnostic procedure requested by the study protocol
  • Enrollment in another study
  • Circumstances or comorbidities which do not allow enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vivantes Klinikum am Urban

Berlin, 10967, Germany

Location

Humbold Klinikum

Berlin, 13509, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20251, Germany

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • H.-C- Ehlers, MD

    Vivantes Klinikum am Urban

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2006

Last Updated

July 3, 2025

Record last verified: 2018-04

Locations

DE(3)