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

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.

Study Overview

• Status: Unknown
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation using cryothermia

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent Pison, MD; Phone Number: + 31 43 3877095; Email: l.pison@mumc.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Centre
    • Contact: Suzanne Philippens; Phone Number: + 31 43 3877095; Email: s.philippens@mumc.nl
    • Principal Investigator: Laurent Pison Pison, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	3 years
comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires	3, 6, 12, 24 and 36 months
number of track complications, both acute (during the procedure) and chronic throughout the trial	3 years
hospitalization rate during a two and a half year follow-up following the initial six months follow-up	3 years

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: November 3, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 8, 2011
• Last Update Submitted That Met QC Criteria: November 7, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AFLIT-PAF 1.2