Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
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.
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 conducted 5 pacemaker studies are a significant placebo effect of
 pacemaker treatment, underpowering and lack of double blinding. The pacemaker intervention
 has been accelerated dual chamber pacing at the time of bradycardia, which may be too late.
 However, a pooling of all data indicate a beneficial effect of pacing.

 Vasodilatation is an obligate element of all vasovagal syncopal episodes and in many also an
 early sign associated with the hyperkinetic empty left ventricle which triggers the reflex
 wave. The principle in closed loop stimulation (CLS) is a continuous surveillance of the
 impedance in the right ventricle which correlates highly with myocardial contractility. When
 contractility is increased significantly atrial pacing with prolonged AV delay is commenced.
 This principle has been used in chronotropic incompetent patients and in one small study of
 patients with vasovagal syncope with a positive outcome. The hypothesis is that the CLS will
 potentially identify an incipient vasovagal attack and be able to prevent the drop in cardiac
 output and bradycardia by early accelerated pacing.

 Patients will be treated 12 months with active pacing (CLS) and then crossed over to 12
 months with passive pacing (VVI, 30 bpm).

 The study will be double blinded, only a technician will know the status of the pacemaker.
Inclusion Criteria:

 -  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 Criteria:

 -  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