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

NCT ID: NCT00251121

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2012-02-29

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Atrial pacing

Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Group Type: EXPERIMENTAL

Mini-invasive electrophysiological study

Intervention Type: OTHER

Transvenous pacing in right heart atrium

Atrial pacing

Intervention Type: OTHER

Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Interventions

Mini-invasive electrophysiological study

Transvenous pacing in right heart atrium

Intervention Type: OTHER

Atrial pacing

Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jan Hysing MD PhD

MD. Cardiologist, medical Department Sykehuset i Telemark

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Hysing, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Cardiologist at Medical Department Sykehuset Telemark

Locations

Sykehuset Telemark

Skien, Telemark, Norway

Countries

Norway

Other Identifiers

S-05116

Identifier Type: -

Identifier Source: org_study_id