Clinical Trials Directory

Trials / Completed

CompletedNCT00251121

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

Mini-invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia, But With a Negative Holter ECG.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Sykehuset Telemark · Other Government
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMini-invasive electrophysiological studyTransvenous pacing in right heart atrium
OTHERAtrial pacingDiagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Timeline

Start date
2005-11-01
Primary completion
2012-02-01
Completion
2012-02-01
First posted
2005-11-09
Last updated
2012-02-09

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT00251121. Inclusion in this directory is not an endorsement.