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| Sponsors and Collaborators: |
Sykehuset Telemark Rikshospitalet HF |
|---|---|
| Information provided by: | Sykehuset Telemark |
| ClinicalTrials.gov Identifier: | NCT00251121 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pre-Excitation Syndromes Paroxysmal Tachycardia Atrial Fibrillation Atrial Flutter Wolff-Parkinson-White Syndrome |
Procedure: Mini-invasive electrophysiological study |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Mini-Invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia, But With a Negative Holter ECG. |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | August 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jan Hysing, M.D. PhD | +47 35003500 ext 4123 | jan.hysing@sthf.no |
| Contact: Rolf F Berntsen, M.D. PhD | +47 23070000 | rolf.franck.berntsen@rikshospitalet.no |
| Norway, Telemark | |
| Sykehuset Telemark | Recruiting |
| Skien, Telemark, Norway, NO-3710 | |
| Contact: Jan Hysing, M.D PhD +47 35003500 jan.hysing@sthf.no | |
| Contact: Rolf F Berntsen, M.D PhD +47 23070000 rolf.franck.berntsen@rikshospitalet.no | |
| Principal Investigator: Jan Hysing, M.D PhD | |
| Sykehuset Telemark | Recruiting |
| Skien, Telemark, Norway, NO-3710 | |
| Principal Investigator: | Jan Hysing, MD. PhD. | Cardiologist at Medical Department Sykehuset Telemark |
More Information
| Study ID Numbers: | S-05116 |
| Study First Received: | November 7, 2005 |
| Last Updated: | November 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00251121 |
| Health Authority: | Norway: Directorate for Health and Social Affairs |
|
Electrophysiological study paroxysmal tachycardia |
|
Wolff-Parkinson-White Syndrome Heart Diseases Cardiovascular Abnormalities Tachycardia Atrial Flutter Parkinson Disease Wolff-Parkinson-White syndrome |
Tachycardia, Paroxysmal Atrial Fibrillation Congenital Abnormalities Heart Defects, Congenital Pre-Excitation Syndromes Arrhythmias, Cardiac |
|
Disease Pathologic Processes Syndrome Cardiovascular Diseases |
