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

This study has been completed.
Oslo University Hospital
Information provided by (Responsible Party):
Jan Hysing MD PhD, Sykehuset Telemark Identifier:
First received: November 7, 2005
Last updated: February 8, 2012
Last verified: February 2012
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.

Condition Intervention
Pre-excitation Syndromes
Paroxysmal Tachycardia
Atrial Fibrillation
Atrial Flutter
Wolff-Parkinson-White Syndrome
Other: Mini-invasive electrophysiological study
Other: Atrial pacing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Mini-invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia, But With a Negative Holter ECG.

Resource links provided by NLM:

Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • 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 %.

  • 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 Outcome Measures:
  • Quality of diagnoses after referral to university ref. centre [ Time Frame: May 2006 - June 2007 ]
    8 patienst were RF abladed in Oslo University Hospital

Enrollment: 51
Study Start Date: November 2005
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atrial pacing
Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
Other: Mini-invasive electrophysiological study
Transvenous pacing in right heart atrium
Other: Atrial pacing
Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00251121

Sykehuset Telemark
Skien, Telemark, Norway, NO-3710
Sponsors and Collaborators
Sykehuset Telemark
Oslo University Hospital
Principal Investigator: Jan Hysing, MD. PhD. Cardiologist at Medical Department Sykehuset Telemark
  More Information

Responsible Party: Jan Hysing MD PhD, MD. Cardiologist, medical Department Sykehuset i Telemark, Sykehuset Telemark Identifier: NCT00251121     History of Changes
Other Study ID Numbers: S-05116
Study First Received: November 7, 2005
Last Updated: February 8, 2012

Keywords provided by Sykehuset Telemark:
Electrophysiological study
paroxysmal tachycardia

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Tachycardia, Paroxysmal
Wolff-Parkinson-White Syndrome
Pre-Excitation Syndromes
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities processed this record on April 21, 2017