Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

NCT01466842 | Unknown

• 1 other identifier: AFLIT-PAF 1.2
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Catheter ablation

OTHER

Procedure: Catheter ablation using cryothermia

Antiarrhythmic drugs

NO INTERVENTION

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

Interventions

Catheter ablation using cryothermia PROCEDURE

Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.

Catheter ablation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laurent Pison, MD

CONTACT

+ 31 43 3877095; l.pison@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 8, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2016
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

NL (1)