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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Pacemaker treatment, pacemaker programmed as active = CLS, Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)
Henning Mølgaard, MD, DMSc
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00292825
- Information obtained from ClinicalTrials.gov on July 15, 2010
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically m...
In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation on cardiac pacemaker function.
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.
To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.
Cough is a common symptom in respiratory medicine. We report on a 60-year-old patient, who developed cough after pacemaker implantation. Diagnostic work up yielded malposition of the right-ventricular...
Magnetic Resonance Imaging (MRI) can be safely performed in patients with MR conditional pacemaker systems, but remains relatively contraindicated with non-MR conditional pacemaker systems.
Long QT syndromes encompass the most prevalent group of ion channelopathies. Long QT syndromes are predominantly familial and predispose the affected individual to ventricular arrhythmias and sudden d...
Pacemaker lead endocarditis is treated with total removal of the infected device and proper antibiotics. The outcomes of patients undergoing percutaneous lead extraction for large vegetations (>2 cm) ...
A pacemaking system consists of an impulse generator and lead or leads to carry the electrical impulse to the patient's heart. Pacemaker and implantable cardioverter defibrillator codes were made to d...
Medical and Biotech [MESH] Definitions
Regulation of the rate of contraction of the heart muscles by an artificial pacemaker.
A device designed to stimulate, by electric impulses, contraction of the heart muscles. It may be temporary (external) or permanent (internal or internal-external).
A type of cardiac arrhythmia with premature atrial contractions or beats caused by signals originating from ectopic atrial sites. The ectopic signals may or may not conduct to the HEART VENTRICLES. Atrial premature complexes are characterized by premature P waves on ECG which are different in configuration from the P waves generated by the normal pacemaker complex in the SINOATRIAL NODE.
A cardiac arrhythmia that is caused by interaction of two independently initiated cardiac impulses of different rates from two separate foci. Generally one focus is the SINOATRIAL NODE, the normal pacemaker. The ectopic focus is usually in the HEART VENTRICLE but can be in the HEART ATRIUM or the ATRIOVENTRICULAR NODE. Modulation of the parasystolic rhythm by the sinus rhythm depends on the completeness of entrance block surrounding the parasystolic focus.
Works consisting of sequenced self-correction texts.