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| Descriptive Information Fields | |||||||||
| 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. | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Number of tachycardia diagnoses previously not known. Number of complications |
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| Secondary Outcome Measure † | Quality of diagnoses after referral to university ref. centre | ||||||||
| Condition † | Pre-Excitation Syndromes Paroxysmal Tachycardia Atrial Fibrillation Atrial Flutter Wolff-Parkinson-White Syndrome |
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| Intervention † | Procedure: Mini-invasive electrophysiological study | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 100 | ||||||||
| Start Date † | November 2005 | ||||||||
| Completion Date | August 2006 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Norway | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00251121 | ||||||||
| Organization ID | S-05116 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Sykehuset Telemark | ||||||||
| Collaborators †† | Rikshospitalet HF | ||||||||
| Investigators † |
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| Information Provided By | Sykehuset Telemark | ||||||||
| Verification Date | October 2005 | ||||||||
| First Received Date † | November 7, 2005 | ||||||||
| Last Updated Date | November 23, 2005 | ||||||||
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