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Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

NCT00292825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-04-01

No results posted yet for this study

Summary

The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker (closed loop stimulation \[CLS\]) which can potentially identify an incipient attack and prevent syncope by pacing.

Conditions

  • Vasovagal Syncope

Interventions

DEVICE

Pacemaker treatment, pacemaker programmed as active = CLS

Pacemaker treatment with closed loop function(CLS)

DEVICE

Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)

pacemaker treatment as VVI 30 bpm

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Henning Mølgaard, MD, DMSc · Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00292825 on ClinicalTrials.gov