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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251121
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : February 9, 2012
Oslo University Hospital
Information provided by (Responsible Party):
Jan Hysing MD PhD, Sykehuset Telemark

Brief 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.

Condition or disease Intervention/treatment Phase
Pre-excitation Syndromes Paroxysmal Tachycardia Atrial Fibrillation Atrial Flutter Wolff-Parkinson-White Syndrome Other: Mini-invasive electrophysiological study Other: Atrial pacing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2005
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251121

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

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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
First Posted: November 9, 2005    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

Keywords provided by Jan Hysing MD PhD, Sykehuset Telemark:
Electrophysiological study
paroxysmal tachycardia

Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Wolff-Parkinson-White Syndrome
Tachycardia, Paroxysmal
Pre-Excitation Syndromes
Accessory Atrioventricular Bundle
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathological Conditions, Anatomical