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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251121
• Other study ID #: S-05116
• Status: Completed
• Phase: N/A
• First received: November 7, 2005
• Last updated: February 8, 2012
• Start date: November 2005
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Paroxysmal Tachycardia
• Pre-excitation Syndromes
• Syndrome
• Tachycardia
• Tachycardia, Paroxysmal
• Wolff-Parkinson-White Syndrome

Intervention

Other:
• Mini-invasive electrophysiological study
Transvenous pacing in right heart atrium
• Atrial pacing
Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Locations

Country	Name	City	State
Norway	Sykehuset Telemark	Skien	Telemark

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Telemark	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of tachycardia diagnoses previously not known.	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 %.	October 2005 to May 2006	Yes
Primary	Primary outcome was the diagnosis of supraventricular tachycardia suitable for ablation	Two patients had to undergo DC conversion for A.fib	Oct 2005 - May 2006	No
Secondary	Quality of diagnoses after referral to university ref. centre	8 patienst were RF abladed in Oslo University Hospital	May 2006 - June 2007	No