Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340314
Status:
COMPLETED
Last Update Posted:
2010-07-28
First Post:
2006-06-19
Brief Title:
A Trial of Circumferential Pulmonary Vein Ablation CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation AF
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
A Controlled Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Treating Paroxysmal Atrial Fibrillation The Ablation for Paroxysmal Atrial Fibrillation APAF2 Trial
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APAF2
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
The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a randomized controlled trial
Detailed Description:
Antiarrhythmic drug therapy ADT is currently considered as first-line therapy in patients with paroxysmal atrial fibrillation AF1 However antiarrhythmic drugs are frequently ineffective and can have serious potential adverse effects thus often offsetting any advantage offered by the maintenance of sinus rhythm SR23 Data from our and other laboratories suggest that pulmonary vein ablation techniques may be a curative alternative for AF obviating the need for ADT andor anticoagulation in many patients4-8 However only preliminary and frequently non-randomized data exists for an evidence-based evaluation of catheter ablation as compared to conventional antiarrhythmic drug therapyADT48 Thus we conducted a controlled randomized trial the Ablation for Paroxysmal Atrial Fibrillation APAF trial to determine the long-term efficacy of circumferential pulmonary vein ablation CPVA in patients with paroxysmal AF as compared with ADT with flecainide sotalol or amiodarone
Methods One hundred ninety-eight patients age 5610 years with PAF duration 65 years mean AF episodes 34month were randomized to CPVA or to ADT with flecainide sotalol or amiodarone Ablation was randomly performed with the use of a standard or an irrigated tip catheter and with CARTO or NavX non fluoroscopic 3D systems guidance Cardiac rhythm was assessed with daily transtelephonic transmissions over a 12 and 48 months follow-up Crossovers to CPVA were allowed after 3 months of ADT
Results By Kaplan-Meier analysis 86 of patients in the CPVA group and 22 in the ADT group were free from recurrent atrial tachyarrhythmias AT P0001 a repeat ablation was performed in 9 of patients in the CPVA group for recurrent AF 6 or atrial tachycardia 3 At 1 year 93 and 35 of the CPVA and ADT groups were AT-free while at 4 years only 727 patients assigned to RFA and 121 assigned to AADs reached the endpointp0001Lower left ejection fraction arterial hypertension and age independently predicted AF recurrences in the ADT group CPVA was associated with a significant decrease in left atrial diameter 1510 P001 and with fewer number of cardiovascular hospitalizations p001 Ablation with an irrigated tip catheter was more effective P003 with either the CARTO or NavX system P008 One transient ischemic attack and one pericardial effusion occurred in the CPVA group side effects of ADT were reported in 23 patientsDuring the 4-year follow-up 87 initially AADs patients required cross over to RFA with a steeper rate at 1 year 42 patients and 19 of them progressed to persistent AF before switching Considering repeat ablation and crossover the overall success rate was 90 in RFA group and 80 in AAD group p00023 by log-rank test New left AT developed in 9 patients requiring mapping and ablation in 7 patients Quality of life was higher in the RFA group than in AAD group for all subscale scores p0001 Conclusions Compared to ADT CPVA can safely and effectively cure PAF in many patients at one-year follow-up and this benefit is extended to 4 years
Methods One hundred ninety-eight patients age 5610 years with PAF duration 65 years mean AF episodes 34month were randomized to CPVA or to ADT with flecainide sotalol or amiodarone Ablation was randomly performed with the use of a standard or an irrigated tip catheter and with CARTO or NavX non fluoroscopic 3D systems guidance Cardiac rhythm was assessed with daily transtelephonic transmissions over a 12 and 48 months follow-up Crossovers to CPVA were allowed after 3 months of ADT
Results By Kaplan-Meier analysis 86 of patients in the CPVA group and 22 in the ADT group were free from recurrent atrial tachyarrhythmias AT P0001 a repeat ablation was performed in 9 of patients in the CPVA group for recurrent AF 6 or atrial tachycardia 3 At 1 year 93 and 35 of the CPVA and ADT groups were AT-free while at 4 years only 727 patients assigned to RFA and 121 assigned to AADs reached the endpointp0001Lower left ejection fraction arterial hypertension and age independently predicted AF recurrences in the ADT group CPVA was associated with a significant decrease in left atrial diameter 1510 P001 and with fewer number of cardiovascular hospitalizations p001 Ablation with an irrigated tip catheter was more effective P003 with either the CARTO or NavX system P008 One transient ischemic attack and one pericardial effusion occurred in the CPVA group side effects of ADT were reported in 23 patientsDuring the 4-year follow-up 87 initially AADs patients required cross over to RFA with a steeper rate at 1 year 42 patients and 19 of them progressed to persistent AF before switching Considering repeat ablation and crossover the overall success rate was 90 in RFA group and 80 in AAD group p00023 by log-rank test New left AT developed in 9 patients requiring mapping and ablation in 7 patients Quality of life was higher in the RFA group than in AAD group for all subscale scores p0001 Conclusions Compared to ADT CPVA can safely and effectively cure PAF in many patients at one-year follow-up and this benefit is extended to 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None