A Comparison of the Drug Therapy Versus Re-Ablation

PHASE2CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

January 31, 2012

Study Completion Date

August 31, 2012

Conditions
Paroxysmal Atrial FibrillationFailed First Radiofrequency Ablation Procedure
Interventions
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.

PROCEDURE

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."

Trial Locations (1)

630055

State Research Institute of Circulation Pathology, Novosibirsk

All Listed Sponsors
lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK

NCT01709682 - A Comparison of the Drug Therapy Versus Re-Ablation | Biotech Hunter | Biotech Hunter