Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC)

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.

Study Overview

• Status: Completed
• Conditions: Vasovagal Syncope
• Intervention / Treatment: Device: Pacemaker treatment, pacemaker programmed as active = CLS; Device: Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Århus N, Denmark, 8200
    • Henning Mølgaard, MD, DMSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period	12 months + 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Aarhus University Hospital; Biotronik SE & Co. KG
• Investigators: Principal Investigator: Henning Mølgaard, MD, DMSc, Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: February 15, 2006
• First Submitted That Met QC Criteria: February 15, 2006
• First Posted (Estimate): February 16, 2006

Study Record Updates

• Last Update Posted (Estimate): April 1, 2010
• Last Update Submitted That Met QC Criteria: March 31, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: syncope; pacing; vasovagal syncope; cardioinhibitory syncope; neurocardiogenic syncope; closed loop pacing; tilt table
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: skejbyH