NCT00251121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

6.3 years

First QC Date

November 7, 2005

Last Update Submit

February 8, 2012

Conditions

Pre-excitation SyndromesParoxysmal TachycardiaAtrial FibrillationAtrial FlutterWolff-Parkinson-White Syndrome

Keywords

Electrophysiological studyparoxysmal tachycardia

Outcome Measures

Primary Outcomes (2)

  • 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 %.

    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

    Oct 2005 - May 2006

Secondary Outcomes (1)

  • Quality of diagnoses after referral to university ref. centre

    May 2006 - June 2007

Study Arms (1)

Atrial pacing

EXPERIMENTAL

Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Other: Mini-invasive electrophysiological studyOther: Atrial pacing

Interventions

Mini-invasive electrophysiological studyOTHER

Transvenous pacing in right heart atrium

Atrial pacing
Atrial pacingOTHER

Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia

Atrial pacing

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of complains of tachycardia
  • No arrythmias detected by a 24 hours Holter ECG
  • Age 19 to 74 years

You may not qualify if:

  • Patients younger than 18 years
  • Patients older than 75

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset Telemark

Skien, Telemark, NO-3710, Norway

Location

MeSH Terms

Conditions

Pre-Excitation SyndromesTachycardia, ParoxysmalAtrial FibrillationAtrial FlutterWolff-Parkinson-White Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseTachycardiaPathologic ProcessesPathological Conditions, Signs and SymptomsHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jan Hysing, MD. PhD.

    Cardiologist at Medical Department Sykehuset Telemark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Cardiologist, medical Department Sykehuset i Telemark

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 9, 2005

Study Start

November 1, 2005

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

NO(1)