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Completed

NCT Number: NCT01709682

A Comparison of the Drug Therapy Versus Re-Ablation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • history of symptomatic PAF

Exclusion criteria

  • congestive heart failure
  • LV ejection fraction < 35%
  • left atrial diameter > 60 mm

Treatment and study plan

Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)

Drug

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

re-ablation procedure

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

Procedure

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.

Primary outcomes

  1. progression of AF (AF burden progression and persistent AF)

    Time frame: 3 year

Secondary outcomes

  1. recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia

    Time frame: 3 years

  2. number of further ablation

    Time frame: 3 years

  3. predictors of AF progression

    Time frame: 3 years

    AF burden by ILR monitoring

  4. complications

    Time frame: 3 years

    • tamponade
    • pulmonary vein stenosis
    • atrio-esophora fistula (for re-ablation arm)
    • ventricular arrhythmia
    • symptomatic bradycardia (for AAD arm)

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 18, 2012
Registry last updated
Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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