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Clinical Trials/EUCTR2008-001384-11-SE
EUCTR2008-001384-11-SE
Active, not recruiting
Not Applicable

Catheter Ablation compared with Pharmacological Therapy for Atrial Fibrillation – the CAPTAF trial - captaf

Not provided0 sites250 target enrollmentMarch 4, 2008
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ConditionsTo study the effect of catheter ablation (using CE marked products) on the quality of life an in patients with atrial fibrillation depsite treatment with conevntional antiarrhythmic medical therapy.atrial fibrillation is thus the disease to be investigatedMedDRA version: 9.1Level: LLTClassification code 10066664Term: Recurrent symptomatic atrial fibrillation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
To study the effect of catheter ablation (using CE marked products) on the quality of life an in patients with atrial fibrillation depsite treatment with conevntional antiarrhythmic medical therapy.atrial fibrillation is thus the disease to be investigated
Sponsor
Not provided
Enrollment
250
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 4, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility Criteria

Inclusion Criteria

  • •1\.Age: 30\-70 years.
  • •2\.Patients with symptoms related to AF, who have failed or been intolerant to at least one drug used for either rate or rhythm control (Vaughan Williams class I, II, or III anti\-arrhythmic drug) thus excluding digitalis and Ca channel inhibitors.
  • •3\.The first diagnosis of AF must have been first noted more than 6 months prior to consideration.
  • •4\.At least one AF episode documented on 12\-lead ECG or 2\-channel telemetry/Holter recording during the previous 12 months.
  • •5\.Paroxysmal AF with occurrence of at least one symptomatic episodes (patient history) in the previous 2 months that merits non\-pharmacological intervention (see classification), or
  • •6\.Persistent AF with occurrence of at least 2 symptomatic episodes of AF in the previous 12 months, necessitating pharmacological or electrical cardioversions (CV), on or off antiarrhythmic drugs that merits non\-pharmacological intervention. Upon cardioversion, it must be documented that sinus rhythm can be maintained for at least 1 hour, to distinguish from permanent AF.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Patients who have tested 2 or more anti\-arrhythmic drugs for rhythm control at highest tolerable dosages (Vaughan Williams class I or III anti\-arrhythmic drug.
  • •2\.AF secondary to a transient or correctable abnormality .
  • •3\.Atrial fibrillation episodes triggered by another uniform SVT.
  • •4\.Untreated or uncontrolled hypertension
  • •5\.Valvular disease requiring chronic anticoagulation or planned valve surgery within 2 years.
  • •6\.Contraindication to treatment with Warfarin or other anticoagulants.
  • •7\.Heart failure with NYHA class III or IV or left ventricular ejection fraction ( \< 35 %.
  • •8\.Left atrial diameter \> 60 mm.
  • •9\.Unstable angina or acute myocardial infarction within last 3 months.
  • •10\.Cardiac revascularization procedure within last 6 months.

Outcomes

Primary Outcomes

Not specified

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