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
  Purpose

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.


Condition Intervention
Paroxysmal Atrial Fibrillation
Procedure: Catheter ablation using cryothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Catheter ablation 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.
No Intervention: Antiarrhythmic drugs
Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466842

Contacts
Contact: Laurent Pison, MD + 31 43 3877095 l.pison@mumc.nl

Locations
Netherlands
Maastricht University Medical Centre Not yet recruiting
Maastricht, Netherlands, 6229 HX
Contact: Suzanne Philippens    + 31 43 3877095    s.philippens@mumc.nl   
Principal Investigator: Laurent Pison Pison, MD         
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01466842     History of Changes
Other Study ID Numbers: AFLIT-PAF 1.2
Study First Received: November 3, 2011
Last Updated: November 7, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014