Status:
COMPLETED
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Aarhus University Hospital
Biotronik SE & Co. KG
Conditions:
Vasovagal Syncope
Eligibility:
All Genders
25+ years
Phase:
NA
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 stimu...
Detailed Description
The treatment of patients with recurrent syncope of vasovagal origin, not precipitated by usual vasovagal factors, and not associated with structural heart disease, is unsolved. The limitations of the...
Eligibility Criteria
Inclusion
- A clinical problem with vasovagal syncope which motivates considerations concerning pacemaker treatment.
- A positive tilt-table test.
- Exclusion of other causes for syncope by a complete diagnostic work-up allowing only minor cardiac abnormalities
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00292825
Start Date
February 1 2006
End Date
March 1 2010
Last Update
April 1 2010
Active Locations (1)
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1
Henning Mølgaard, MD, DMSc
Århus N, Århus N, Denmark, 8200