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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter; Wolff-Parkinson-White Syndrome; Pre-excitation Syndromes; Paroxysmal Tachycardia
• Intervention / Treatment: Other: Mini-invasive electrophysiological study; Other: Atrial pacing

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
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Telemark
    • Skien, Telemark, Norway, NO-3710
      • Sykehuset Telemark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of diagnoses after referral to university ref. centre	8 patienst were RF abladed in Oslo University Hospital	May 2006 - June 2007

Collaborators and Investigators

• Sponsor: Sykehuset Telemark
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: Jan Hysing, MD. PhD., Cardiologist at Medical Department Sykehuset Telemark

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 7, 2005
• First Submitted That Met QC Criteria: November 7, 2005
• First Posted (Estimate): November 9, 2005

Study Record Updates

• Last Update Posted (Estimate): February 9, 2012
• Last Update Submitted That Met QC Criteria: February 8, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Electrophysiological study; paroxysmal tachycardia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Syndrome; Atrial Fibrillation; Tachycardia; Atrial Flutter; Pre-Excitation Syndromes; Wolff-Parkinson-White Syndrome; Accessory Atrioventricular Bundle; Tachycardia, Paroxysmal
• Other Study ID Numbers: S-05116