Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

01:41 EST 24th November 2014 | 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 [306 Associated Clinical Trials listed on BioPortfolio]

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.

Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.

To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.

PubMed Articles [21905 Associated PubMed Articles listed on BioPortfolio]

Analysis of a five year experience of permanent pacemaker implantation at a Nigerian Teaching Hospital: need for a national database.

Permanent pacemaker implantation is available in Nigeria. There is however no national registry or framework for pacemaker data collection. A pacemaker database has been developed in our institution a...

Pacemaker failure due to loss of fluid seal in a patient with a 5/6mm pacemaker header port and a 5mm unipolar lead.

Before IS-1 (3.2 mm) standardization of pacemaker leads and connectors, 5/6 mm connector ports accomodated 5mm or 6mm diameter lead connector pins.

Successful implantation of a dual-chamber pacemaker in an ELBW infant for long QT syndrome.

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...

Aspergillus pacemaker lead endocarditis.

A 47-year-old man who had a pacemaker implanted 2 years earlier, recently developed a fever and had been on antibiotics for 2 months. He presented with pulmonary emboli, and underwent lead extraction ...

Transvenous pacemaker lead removal in pacemaker lead endocarditis with large vegetations: a report of two cases.

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) ...

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.

More From BioPortfolio on "Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope"

Search BioPortfolio:
Loading
Advertisement

Relevant Topic

Alzheimer's Disease
Latest News Clinical Trials Research Drugs Reports Corporate
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Advertisement