Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

Vasovagal Syncope Clinical Trial

Official title:

SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292825
• Other study ID #: skejbyH
• Status: Completed
• Phase: N/A
• First received: February 15, 2006
• Last updated: March 31, 2010
• Start date: February 2006
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal
• Vasovagal Syncope

Intervention

Device:
• Pacemaker treatment, pacemaker programmed as active = CLS
Pacemaker treatment with closed loop function(CLS)
• Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)
pacemaker treatment as VVI 30 bpm

Locations

Country	Name	City	State
Denmark	Henning Mølgaard, MD, DMSc	Århus N

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Aarhus University Hospital, Biotronik SE & Co. KG

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period		12 months + 12 months	No
Secondary	Number of syncopal and presyncopal episodes, active versus passive pacing period		12 months+12 months	No
Secondary	Quality of life, active versus passive pacing period		12 months+12 months	No