NCT00340314

Brief Summary

Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been formally assessed in a randomized controlled trial. The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
Last Updated

July 28, 2010

Status Verified

May 1, 2006

First QC Date

June 19, 2006

Last Update Submit

July 27, 2010

Conditions

Atrial Fibrillation

Keywords

symptomaticparoxysmalatrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.

Secondary Outcomes (11)

  • Presence of SR during 1-month intervals

  • Percent of patients totally free of AF

  • Number of cardioversions

  • LV function

  • Incidence of cardiovascular hospitalization

  • +6 more secondary outcomes

Interventions

Circumferential Pulmonary Vein AblationPROCEDURE
Antiarrhythmic Drug TherapyDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • History of symptomatic paroxysmal AF lasting more than 6 months. Paroxysms of AF are intended as recurrent self-terminating episodes lasting less than 7 days and occurring more than 2 times every month.

You may not qualify if:

  • Pregnancy
  • NYHA functional class III or IV
  • Left atrial size \> 65 mm
  • Left ventricular (LV) ejection fraction \< 35%
  • Contraindication to anticoagulation with warfarin
  • History of myocardial infarction within six months of the procedure
  • Prior catheter or surgical ablation attempt for AF
  • Inability or unwillingness to provide written informed consent
  • Life expectancy less than 1 year
  • Significant comorbid conditions such as: cancer (not cured), end stage renal disease (creatinine clearance \< 20 mL/h), severe chronic obstructive lung disease, cirrhosis, etc)
  • Anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease.
  • Presence of left atrial thrombus.
  • Prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal doses (target 200 mg, 240 mg, 200 mg daily respectively
  • AF burden \< 2 episodes/month
  • WPW
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele University Hospital

Milan, 20132, Italy

Location

Related Publications (2)

  • Pappone C, Vicedomini G, Augello G, Manguso F, Saviano M, Baldi M, Petretta A, Giannelli L, Calovic Z, Guluta V, Tavazzi L, Santinelli V. Radiofrequency catheter ablation and antiarrhythmic drug therapy: a prospective, randomized, 4-year follow-up trial: the APAF study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):808-14. doi: 10.1161/CIRCEP.111.966408. Epub 2011 Sep 23.

    PMID: 21946315DERIVED

  • Pappone C, Augello G, Sala S, Gugliotta F, Vicedomini G, Gulletta S, Paglino G, Mazzone P, Sora N, Greiss I, Santagostino A, LiVolsi L, Pappone N, Radinovic A, Manguso F, Santinelli V. A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. J Am Coll Cardiol. 2006 Dec 5;48(11):2340-7. doi: 10.1016/j.jacc.2006.08.037. Epub 2006 Oct 16.

    PMID: 17161267DERIVED

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carlo Pappone, MD, PhD

    San Raffaele University Hospital, Villa Maria Cecilia Hospital, Cotignola (Ravenna), Italy

    PRINCIPAL INVESTIGATOR

  • Vincenzo Santinelli, MD

    San Raffaele University Hospital, Villa Maria Cecilia Hospital, Cotignola (Ravenna), Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

January 1, 2005

Study Completion

May 1, 2006

Last Updated

July 28, 2010

Record last verified: 2006-05

Locations

IT(1)