Clinical trial NCT00251121: Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECG
Official title: Mini-invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia, But With a Negative Holter ECG.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-excitation Syndromes
Paroxysmal Tachycardia
Atrial Fibrillation
Atrial Flutter
Wolff-Parkinson-White Syndrome
Keywords: Electrophysiological study
paroxysmal tachycardia
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
First posted: 2005-11-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of tachycardia diagnoses previously not known.
timeFrame: October 2005 to May 2006
measure: Primary outcome was the diagnosis of supraventricular tachycardia suitable for ablation
timeFrame: Oct 2005 - May 2006
Secondary outcomes:
measure: Quality of diagnoses after referral to university ref. centre
timeFrame: May 2006 - June 2007
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Sykehuset Telemark
state: Telemark
Study officials:
affiliation: Cardiologist at Medical Department Sykehuset Telemark
name: Jan Hysing, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: