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Completed

NCT Number: NCT00251121

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

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.

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Key information

Conditions

Pre-excitation Syndromes Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Paroxysmal Tachycardia Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Paroxysmal Wolff-Parkinson-White Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset Telemark

Skien, Telemark, NO-3710, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini-invasive electrophysiological study

Other

Transvenous pacing in right heart atrium

Atrial pacing

Other

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

Primary outcomes

  1. Number of tachycardia diagnoses previously not known.

    Time frame: October 2005 to May 2006

    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 %.

  2. Primary outcome was the diagnosis of supraventricular tachycardia suitable for ablation

    Time frame: Oct 2005 - May 2006

    Two patients had to undergo DC conversion for A.fib

Secondary outcomes

  1. Quality of diagnoses after referral to university ref. centre

    Time frame: May 2006 - June 2007

    8 patienst were RF abladed in Oslo University Hospital

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2005
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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