A Comparison of the Drug Therapy Versus Re-Ablation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Paroxysmal Atrial Fibrillation Failed First Radiofrequency Ablation Procedure	Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone) Procedure: re-ablation procedure Procedure: ILR implantation	Phase 2


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

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Sotalol hydrochloride Amiodarone Sotalol Propafenone hydrochloride Propafenone Flecainide Flecainide acetate

U.S. FDA Resources

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:

progression of AF (AF burden progression and persistent AF) [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia [ Time Frame: 3 years ] [ Designated as safety issue: No ]
number of further ablation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
predictors of AF progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
AF burden by ILR monitoring
complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- tamponade
- pulmonary vein stenosis
- atrio-esophora fistula (for re-ablation arm)
- ventricular arrhythmia
- symptomatic bradycardia (for AAD arm)


Enrollment:	154
Study Start Date:	November 2007
Study Completion Date:	August 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: AAD therapy Recurrent episodes were pharmacologically managed by conventional AAD therapy (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) according to AF management guidelines.	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: 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.
Active Comparator: 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. Only in patients with induced left atrial flutter, additional RF ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs.	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.

Arms

Assigned Interventions

Active Comparator: AAD therapy

Recurrent episodes were pharmacologically managed by conventional AAD therapy (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) according to AF management guidelines.

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: 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.

Active Comparator: 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. Only in patients with induced left atrial flutter, additional RF ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs.

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

history of symptomatic PAF

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709682

Locations


Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators


Principal Investigator:	Evgeny Pokushalov, MD, PhD	State Research Institute of Circulation Pathology

More Information

Additional Information:

State Research Institute of Circulation Pathology Official Site This link exits the ClinicalTrials.gov site

No publications provided by Meshalkin Research Institute of Pathology of Circulation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pokushalov E, Romanov A, De Melis M, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):754-60. doi: 10.1161/CIRCEP.113.000495. Epub 2013 Jun 7.


Responsible Party:	Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:	NCT01709682 History of Changes
Other Study ID Numbers:	PAF-DT-RA
Study First Received:	October 11, 2012
Last Updated:	October 16, 2012
Health Authority:	Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:


atrial fibrillation arrhythmias anti-arrhythmic agents

Additional relevant MeSH terms:


Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Anti-Arrhythmia Agents Propafenone	Cardiovascular Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Sodium Channel Blockers Therapeutic Uses Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on February 27, 2015