A Comparison of the Drug Therapy Versus Re-Ablation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Progression of Atrial Fibrillation After a Failed Initial Ablation Procedure in Patients With Paroxysmal Atrial Fibrillation: A Randomized Comparison of the Drug Therapy Versus Re-Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709682
• Other study ID #: PAF-DT-RA
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2012
• Last updated: October 16, 2012
• Start date: November 2007
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy (control) in patients with previous failed PVI ablation for paroxysmal AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• history of symptomatic PAF

Exclusion Criteria:

• congestive heart failure

• LV ejection fraction < 35%

• left atrial diameter > 60 mm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Failed First Radiofrequency Ablation Procedure
• Paroxysmal Atrial Fibrillation

Intervention

Drug:
• Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)
propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure

Procedure:
• re-ablation procedure
Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.
• ILR implantation
The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude =0.4 mV assessed through the Vector Check. Patients were provided with the Patient Assistant, a tool that allows each patient to store the ECG through the implanted device during symptoms; data were collected in order to analyze heart rhythm during symptomatic events.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression of AF (AF burden progression and persistent AF)		3 year	No
Secondary	recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia		3 years	No
Secondary	number of further ablation		3 years	No
Secondary	predictors of AF progression	AF burden by ILR monitoring	3 years	No
Secondary	complications	tamponade; pulmonary vein stenosis; atrio-esophora fistula (for re-ablation arm); ventricular arrhythmia; symptomatic bradycardia (for AAD arm)	3 years	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site