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

Brief Title

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

Official Title

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

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.
    

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.
    


Study Type

Interventional


Primary Outcome

Number of tachycardia diagnoses previously not known.

Secondary Outcome

 Quality of diagnoses after referral to university ref. centre

Condition

Pre-excitation Syndromes

Intervention

Mini-invasive electrophysiological study

Study Arms / Comparison Groups

 Atrial pacing
Description:  Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

51

Start Date

November 2005

Completion Date

February 2012

Primary Completion Date

February 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jan Hysing, MD. PhD., , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT00251121

Organization ID

S-05116


Responsible Party

Principal Investigator

Study Sponsor

Sykehuset Telemark

Collaborators

 Oslo University Hospital

Study Sponsor

Jan Hysing, MD. PhD., Principal Investigator, Cardiologist at Medical Department Sykehuset Telemark


Verification Date

February 2012