Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECG - Full Text View

Sponsor:	Sykehuset Telemark
Collaborator:	Oslo University Hospital
Information provided by (Responsible Party):	Jan Hysing MD PhD, Sykehuset Telemark
ClinicalTrials.gov Identifier:	NCT00251121

Purpose

Patients complaining of tachycardia but with a negative Holter ECG, are for a limited time period offered a simplified electrophysiological(EP) examination. By a full electrophysiological study(EP study)electrodes are introduced for pacing and sensing i all four heart chambers. Where as by the mini invasive EP study only one electrode is introduced to the right atrium. The simplified procedure represent a smaller risk of complications, requires less resources but should yield the same diagnoses in more than 90% of the cases. The study is a feasibility study to see if the procedure can discover arrythmias in a fairly unselected patient population.

Condition	Intervention
Pre-excitation Syndromes Paroxysmal Tachycardia Atrial Fibrillation Atrial Flutter Wolff-Parkinson-White Syndrome	Other: Mini-invasive electrophysiological study Other: Atrial pacing

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Mini-invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia, But With a Negative Holter ECG.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome short QT syndrome Wolff-Parkinson-White syndrome

MedlinePlus related topics: Atrial Fibrillation Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:

Number of tachycardia diagnoses previously not known. [ Time Frame: October 2005 to May 2006 ] [ Designated as safety issue: Yes ]
A simple electrophysiologic examination uncovered reentry tachycardia in nine patients and paroxystic atrial flutter in three patients. A total of 56 electrophysiologic examinations were performed, uncovering 12 cases of tachycardia suitable for ablation. Two patients had to undergo DC-conversion, no other complication was observed.

Interpretation. A simplified electrophysiologic examination of this group of patients will uncover tachycardia suitable for ablation in approximately 20 % of the patients, and increase diagnostic yield of supraventricular tachycardia by 64 %.
Primary outcome was the diagnosis of supraventricular tachycardia suitable for ablation [ Time Frame: Oct 2005 - May 2006 ] [ Designated as safety issue: No ]
Two patients had to undergo DC conversion for A.fib

Secondary Outcome Measures:

Quality of diagnoses after referral to university ref. centre [ Time Frame: May 2006 - June 2007 ] [ Designated as safety issue: No ]
8 patienst were RF abladed in Oslo University Hospital

Enrollment:	51
Study Start Date:	November 2005
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Atrial pacing Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia	Other: Mini-invasive electrophysiological study Transvenous pacing in right heart atrium Other: Atrial pacing Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Detailed Description:

Sykehuset Telemark performs every year approximately 800 Holter ECG examinations. Approximately 200 of these are on the indications tachycardia, and in about 170 patients the examination does not discover any tachycardia Patients who were examined in the period from August 1. 2004 to November 1. 2005 with a negative Holter are mailed a letter with information of the min invasive electrophysiological examination, and an offer of volunteer participation. Patients given their informed consent are then according to waiting list called for the mini-invasive EP-study.

The protocol of the EP stimulation consists of: determination of pacing threshold, pacing with 8 asynchronous beats 600ms and an extrasystole with decremental intervals from 550 ms to 200 ms. The seri is repeated with pacing on 400ms and with two extrasystoles as well as with isoprenaline stimulation.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of complains of tachycardia
No arrythmias detected by a 24 hours Holter ECG
Age 19 to 74 years

Exclusion Criteria:

Patients younger than 18 years
Patients older than 75

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251121

Locations

Norway
Sykehuset Telemark
Skien, Telemark, Norway, NO-3710

Sponsors and Collaborators

Sykehuset Telemark

Oslo University Hospital

Investigators

Principal Investigator:

Jan Hysing, MD. PhD.

Cardiologist at Medical Department Sykehuset Telemark

More Information

No publications provided

Responsible Party:	Jan Hysing MD PhD, MD. Cardiologist, medical Department Sykehuset i Telemark, Sykehuset Telemark
ClinicalTrials.gov Identifier:	NCT00251121 History of Changes
Other Study ID Numbers:	S-05116
Study First Received:	November 7, 2005
Last Updated:	February 8, 2012
Health Authority:	Norway: Directorate for Health and Social Affairs

Keywords provided by Sykehuset Telemark:

Electrophysiological study
paroxysmal tachycardia

Additional relevant MeSH terms:

Atrial Fibrillation
Atrial Flutter
Parkinson Disease
Pre-Excitation Syndromes
Wolff-Parkinson-White Syndrome
Tachycardia
Tachycardia, Paroxysmal
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 12, 2012