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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Catheter ablation using cryothermia
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Catheter ablation

Antiarrhythmic drugs

Arm Description

Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted.

Outcomes

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

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

Full Information

First Posted
November 3, 2011
Last Updated
November 7, 2011
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01466842
Brief Title
Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
Acronym
AFLIT-PAF
Official Title
Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Catheter ablation
Arm Type
Other
Arm Title
Antiarrhythmic drugs
Arm Type
No Intervention
Arm Description
Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation using cryothermia
Intervention Description
Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
number of track complications, both acute (during the procedure) and chronic throughout the trial
Time Frame
3 years
Title
hospitalization rate during a two and a half year follow-up following the initial six months follow-up
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Pison, MD
Phone
+ 31 43 3877095
Email
l.pison@mumc.nl
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Philippens
Phone
+ 31 43 3877095
Email
s.philippens@mumc.nl
First Name & Middle Initial & Last Name & Degree
Laurent Pison Pison, MD

12. IPD Sharing Statement

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Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

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