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

Sponsor
Sykehuset Telemark (Other)
Overall Status
Completed
CT.gov ID
NCT00251121
Collaborator
Oslo University Hospital (Other)
51
1
1
75
0.7

Study Details

Study Description

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
  • Other: Mini-invasive electrophysiological study
  • Other: Atrial pacing
N/A

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 Design

Study Type:
Interventional
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 :
Nov 1, 2005
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of tachycardia diagnoses previously not known. [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 [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 [May 2006 - June 2007]

    8 patienst were RF abladed in Oslo University Hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sykehuset Telemark Skien Telemark Norway NO-3710

Sponsors and Collaborators

  • Sykehuset Telemark
  • Oslo University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan Hysing MD PhD, MD. Cardiologist, medical Department Sykehuset i Telemark, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00251121
Other Study ID Numbers:
  • S-05116
First Posted:
Nov 9, 2005
Last Update Posted:
Feb 9, 2012
Last Verified:
Feb 1, 2012
Keywords provided by Jan Hysing MD PhD, MD. Cardiologist, medical Department Sykehuset i Telemark, Sykehuset Telemark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2012