Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251121
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2005-11-07
Brief Title:
Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia With a Negative Holter ECG
Sponsor:
Sykehuset Telemark
Organization:
Sykehuset Telemark
Study Overview
Official Title:
Mini-invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia But With a Negative Holter ECG
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients complaining of tachycardia but with a negative Holter ECG are for a limited time period offered a simplified electrophysiologicalEP examination By a full electrophysiological studyEP studyelectrodes 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None