Pre-excitation SyndromesNCT00251121
Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECG
A study testing Mini-invasive electrophysiological study and Atrial pacing in people with Pre-excitation Syndromes and Paroxysmal Tachycardia, run by Sykehuset Telemark at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pre-excitation Syndromes, Paroxysmal Tachycardia, Atrial Fibrillation
- What is being tested?
- Mini-invasive electrophysiological study and Atrial pacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2005to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of complains of tachycardia
- No arrythmias detected by a 24 hours Holter ECG
- Age 19 to 74 years
Who cannot join
- Patients younger than 18 years
- Patients older than 75
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pre-excitation Syndromes, Paroxysmal Tachycardia, Atrial Fibrillation, Atrial Flutter, Wolff-Parkinson-White Syndrome
- Being tested
- Mini-invasive electrophysiological study, Atrial pacing
- Keywords
- Electrophysiological study, paroxysmal tachycardia
- Medical subject headings
- Pre-Excitation Syndromes, Tachycardia, Paroxysmal, Atrial Fibrillation, Atrial Flutter, Wolff-Parkinson-White Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-invasive electrophysiological studyOther
Transvenous pacing in right heart atrium
Atrial pacingOther
Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
| Study group | Role | What they receive |
|---|---|---|
| Atrial pacing | Experimental | Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia Receives: Other: Mini-invasive electrophysiological study; Other: Atrial pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %.
Measured: 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
Measured: Oct 2005 - May 2006
Secondary outcomes (1)
Quality of diagnoses after referral to university ref. centre
8 patienst were RF abladed in Oslo University Hospital
Measured: May 2006 - June 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-excitation SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Jan Hysing MD PhD, Sykehuset Telemark
- Investigators
- Jan Hysing, MD. PhD., Principal investigator, Cardiologist at Medical Department Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251121
- Sponsor's protocol ID
- S-05116
- Status last verified
- Feb 2012
- First submitted
- 7 Nov 2005
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-invasive Electrophysiology Study as a Routine Examination for Patients Complaining of Tachycardia, But With a Negative Holter ECG.
- ClinicalTrials.gov ID
- NCT00251121
- Acronym / sponsor ID
- S-05116
- Conditions
- Pre-excitation Syndromes, Paroxysmal Tachycardia, Atrial Fibrillation, Atrial Flutter, Wolff-Parkinson-White Syndrome
- Keywords
- Electrophysiological study, paroxysmal tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Oslo University Hospital
- Study start
- Nov 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial pacing | Experimental | Other: Mini-invasive electrophysiological study, Other: Atrial pacingDiagnostic pacing in right heart atrium in order to unmask reentry tachycardia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of complains of tachycardia
- No arrythmias detected by a 24 hours Holter ECG
- Age 19 to 74 years
Key exclusion criteria (2 listed)
- Patients younger than 18 years
- Patients older than 75
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-invasive electrophysiological studyTransvenous pacing in right heart atrium | Other | Atrial pacing |
| Atrial pacingDiagnostic pacing in right heart atrium in order to unmask reentry tachycardia | Other | Atrial pacing |
Primary outcome
Number of tachycardia diagnoses previously not known.
Time frame: October 2005 to May 2006
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
Time frame: Oct 2005 - May 2006
Two patients had to undergo DC conversion for A.fib
1 secondary outcome
Quality of diagnoses after referral to university ref. centre
Time frame: May 2006 - June 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
Related trials for Pre-excitation Syndromes
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AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
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ATR 1072 in Participants With PRKAG2 Syndrome
Cardiac Glycogenosis, Cardiomyopathy
Not yet recruitingObservational study
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome
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AI-ECG Accessory Pathway Localisation Study
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Longitudinal Evaluation of Active-Duty Personnel with Accessory Pathways (LEAD-AP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Hysing, MD. PhD. principal investigator
Cardiologist at Medical Department Sykehuset Telemark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-invasive electrophysiological study and Atrial pacing in people with Pre-excitation Syndromes and Paroxysmal Tachycardia, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tachycardia diagnoses previously not known. (time frame: October 2005 to May 2006). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.