ClinicalTrials.gov processed this data on March 27, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00251121S-05116NCT00251121Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECGMini-invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia, But With a Negative Holter ECG.Sykehuset TelemarkOtherOslo University HospitalOtherNo
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.
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.
CompletedNovember 2005February 2012February 2012N/AInterventionalNoNon-RandomizedSingle Group AssignmentDiagnosticNone (Open Label)Number of tachycardia diagnoses previously not known.October 2005 to May 2006A 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 ablationOct 2005 - May 2006Two patients had to undergo DC conversion for A.fibQuality of diagnoses after referral to university ref. centreMay 2006 - June 20078 patienst were RF abladed in Oslo University Hospital151Pre-excitation SyndromesParoxysmal TachycardiaAtrial FibrillationAtrial FlutterWolff-Parkinson-White SyndromeAtrial pacingExperimentalDiagnostic pacing in right heart atrium in order to unmask reentry tachycardiaOtherMini-invasive electrophysiological studyTransvenous pacing in right heart atriumAtrial pacingOtherAtrial pacingDiagnostic pacing in right heart atrium in order to unmask reentry tachycardiaAtrial pacing
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
All18 Years75 YearsNoJan Hysing, MD. PhD.Principal InvestigatorCardiologist at Medical Department Sykehuset TelemarkSykehuset TelemarkSkienTelemarkNO-3710NorwayNorwayFebruary 2012November 7, 2005November 7, 2005November 9, 2005February 8, 2012February 8, 2012February 9, 2012Principal InvestigatorSykehuset TelemarkJan Hysing MD PhDMD. Cardiologist, medical Department Sykehuset i TelemarkElectrophysiological studyparoxysmal tachycardiaAtrial FibrillationTachycardiaAtrial FlutterWolff-Parkinson-White SyndromePre-Excitation SyndromesTachycardia, ParoxysmalSyndromeAccessory Atrioventricular Bundle