Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

NCT00292825 | Completed

• 1 other identifier: skejbyH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vasovagal syncope; syncope; cardioinhibitory syncope; neurocardiogenic syncope; pacing; closed loop pacing; tilt table

Outcome Measures

Primary Outcomes (1)

• Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period

  12 months + 12 months

Secondary Outcomes (2)

• Number of syncopal and presyncopal episodes, active versus passive pacing period

  12 months+12 months

• Quality of life, active versus passive pacing period

  12 months+12 months

Interventions

Pacemaker treatment, pacemaker programmed as active = CLS DEVICE

Pacemaker treatment with closed loop function(CLS)

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

pacemaker treatment as VVI 30 bpm

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical problem with vasovagal syncope which motivates considerations concerning pacemaker treatment.
• A positive tilt-table test.
• Syncope for \>= 2 years.
• Number of syncopal episodes \>= 3
• At least 1 instance of syncope within the last 6 months.
• A positive tilt-table test which reproduces the clinical syncope and is associated with a clearly abnormal haemodynamic response:
• Vasovagal Syncope International Study (VASIS) type 1 with bradycardia \< 40 bpm, or
• VASIS type 2A, or
• VASIS type 2B
• Stable clinical condition
• Able to accept and follow the protocol and give written consent.

You may not qualify if:

• Conventional indication for pacemaker (i.e. atrioventricular \[AV\] block)
• Indication for cardiac resynchronisation therapy (i.e. left bundle branch block \[LBBB\])
• Documented atrial fibrillation or flutter
• Epilepsy
• Congestive heart failure
• History of myocardial infarction (MI) or angina pectoris
• Serious chronic disease, life expectancy \< 3 years.
• Age \< 25 years
• Pregnant and lactating women
• Participating in other investigation

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Aarhus University Hospital: collaborator
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

Henning Mølgaard, MD, DMSc

Århus N, Århus N, 8200, Denmark

Location

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henning Mølgaard, MD, DMSc

  Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: February 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 1, 2010

Record last verified: 2010-03

Locations

DK (1)