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

Sykehuset Telemark

Status: Completed

Conditions: Atrial Flutter; Atrial Fibrillation; Paroxysmal Tachycardia; Wolff-Parkinson-White Syndrome; Pre-excitation Syndromes

Treatments: Other: Mini-invasive electrophysiological study; Other: Atrial pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT00251121

S-05116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Atrial pacing

Experimental group

Description:

Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Treatment:

Other: Mini-invasive electrophysiological study

Other: Atrial pacing