Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation (AFLIT-PAF)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01466842
First received: November 3, 2011
Last updated: November 7, 2011
Last verified: November 2011

November 3, 2011
November 7, 2011
January 2012
January 2013   (final data collection date for primary outcome measure)
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01466842 on ClinicalTrials.gov Archive Site
  • any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires [ Time Frame: 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • number of track complications, both acute (during the procedure) and chronic throughout the trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • hospitalization rate during a two and a half year follow-up following the initial six months follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
Procedure: Catheter ablation using cryothermia
Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.
  • Catheter ablation
    Intervention: Procedure: Catheter ablation using cryothermia
  • No Intervention: Antiarrhythmic drugs
    Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
January 2016
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 65
  • At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
  • Never taken antiarrhythmic drugs or at most a pill in the pocket approach
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations

Exclusion Criteria:

  • Paroxysmal AF for more than three years
  • An episode of atrial fibrillation that lasted more than seven days within the past six months
  • Persistent/permanent atrial fibrillation
  • Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
  • Documented atrial flutter
  • Structural heart disease of clinical significance including:

    • Cardiac surgery within six months of screening
    • Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction <30% as measured by echocardiography or catheterization
    • Unstable angina
    • Myocardial infarction within six months of screening
    • Surgically corrected atrial septal defect with a patch or closure device
    • LA size > 40mm
  • Any prior ablation of the pulmonary veins
  • Enrollment in any other ongoing protocol
  • Untreatable allergy to contrast media
  • Pregnancy
  • Any contraindication to cardiac catheterization
  • Prosthetic mitral heart valve
  • Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
  • Contraindication to coumadin or heparin
  • History of pulmonary embolus or stroke within one year of screening
  • Acute pulmonary edema
  • Atrial clot on TEE regardless of the patient's anticoagulation medication status
Both
18 Years to 65 Years
No
Contact: Laurent Pison, MD + 31 43 3877095 l.pison@mumc.nl
Netherlands
 
NCT01466842
AFLIT-PAF 1.2
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Not Provided
Maastricht University Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP