Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

11:44 EDT 27th May 2015 | BioPortfolio

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.

Study Design

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

Conditions

Vasovagal Syncope

Intervention

Pacemaker treatment, pacemaker programmed as active = CLS, Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)

Location

Henning Mølgaard, MD, DMSc
Århus N
Denmark
8200

Status

Completed

Source

Skejby Hospital

Results (where available)

View Results

Links

Clinical Trials [327 Associated Clinical Trials listed on BioPortfolio]

The LEADLESS Pacemaker IDE Study (Leadless II)

Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.

Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker

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...

A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for Regional Anesthesia

In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation on cardiac pacemaker function.

Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies

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.

PubMed Articles [22526 Associated PubMed Articles listed on BioPortfolio]

Cough as a Rare Symptom of a Pacemaker Lead Perforation.

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...

Neck Pain One Week after Pacemaker Generator Replacement.

The incidence of cardiac pacemaker implantation has risen markedly in the past three decades, making awareness of possible postprocedural complications critical to the emergency physician. This case i...

The influence of cholinesterase inhibitor therapy for dementia on risk of cardiac pacemaker insertion: a retrospective, population-based, health administrative databases study in Ontario, Canada.

Cholinesterase inhibitors are used to treat the symptoms of dementia and can theoretically cause bradycardia. Previous studies suggest that patients taking these medications have an increased risk of ...

Prevalence of E/A Wave Fusion and A Wave Truncation in DDD Pacemaker Patients with Complete AV Block under Nominal AV Intervals.

Optimization of the AV-interval (AVI) in DDD pacemakers improves cardiac hemodynamics and reduces pacemaker syndromes. Manual optimization is typically not performed in clinical routine. In the presen...

MRI scanning in patients with new and existing CapSureFix(®) Novus 5076 pacemaker leads: randomized trial results.

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.

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.

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