Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECG
Primary Purpose
Pre-excitation Syndromes, Paroxysmal Tachycardia, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Mini-invasive electrophysiological study
Atrial pacing
Sponsored by
About this trial
This is an interventional diagnostic trial for Pre-excitation Syndromes focused on measuring Electrophysiological study, paroxysmal tachycardia
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
Sites / Locations
- Sykehuset Telemark
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atrial pacing
Arm Description
Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
Outcomes
Primary Outcome Measures
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 %.
Primary outcome was the diagnosis of supraventricular tachycardia suitable for ablation
Two patients had to undergo DC conversion for A.fib
Secondary Outcome Measures
Quality of diagnoses after referral to university ref. centre
8 patienst were RF abladed in Oslo University Hospital
Full Information
NCT ID
NCT00251121
First Posted
November 7, 2005
Last Updated
February 8, 2012
Sponsor
Sykehuset Telemark
Collaborators
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00251121
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset Telemark
Collaborators
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-excitation Syndromes, Paroxysmal Tachycardia, Atrial Fibrillation, Atrial Flutter, Wolff-Parkinson-White Syndrome
Keywords
Electrophysiological study, paroxysmal tachycardia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrial pacing
Arm Type
Experimental
Arm Description
Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
Intervention Type
Other
Intervention Name(s)
Mini-invasive electrophysiological study
Intervention Description
Transvenous pacing in right heart atrium
Intervention Type
Other
Intervention Name(s)
Atrial pacing
Intervention Description
Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
Primary Outcome Measure Information:
Title
Number of tachycardia diagnoses previously not known.
Description
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 %.
Time Frame
October 2005 to May 2006
Title
Primary outcome was the diagnosis of supraventricular tachycardia suitable for ablation
Description
Two patients had to undergo DC conversion for A.fib
Time Frame
Oct 2005 - May 2006
Secondary Outcome Measure Information:
Title
Quality of diagnoses after referral to university ref. centre
Description
8 patienst were RF abladed in Oslo University Hospital
Time Frame
May 2006 - June 2007
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hysing, MD. PhD.
Organizational Affiliation
Cardiologist at Medical Department Sykehuset Telemark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Telemark
City
Skien
State/Province
Telemark
ZIP/Postal Code
NO-3710
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECG
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