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Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

NCT ID: NCT01505296

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-01-31

Brief Summary

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The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.

Detailed Description

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Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.

Conditions

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Atrial Fibrillation

Keywords

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Catheter ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antiarrhythmic drug

Class I or III antiarrhythmic drug

Group Type ACTIVE_COMPARATOR

Antiarrhythmic drug

Intervention Type DRUG

propafenone, flecainide, sotalol, dofetilide

Catheter ablation

Pulmonary vein isolation

Group Type EXPERIMENTAL

Catheter ablation

Intervention Type PROCEDURE

Complete PVI

Interventions

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Antiarrhythmic drug

propafenone, flecainide, sotalol, dofetilide

Intervention Type DRUG

Catheter ablation

Complete PVI

Intervention Type PROCEDURE

Other Intervention Names

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Rhythmol, Tambocor, Betapace, Tikosyn Thermocool

Eligibility Criteria

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Inclusion Criteria

* Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy

Exclusion Criteria

* Previous treatment with Class IC or class III AAD
* Previous AF ablation procedure
* Congestive heart failure (NYHA III-IV functional class)
* Left Ventricle ejection fraction less than 35%
* Left atrial diameter \> 55mm
* Unwillingness to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role collaborator

Valley Health System

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Steinberg,MD

Director Arrhythmia Services, Valley Health System

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Steinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Health System

Evegny Pokushalou, MD

Role: PRINCIPAL_INVESTIGATOR

State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia

Locations

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Valley Health System

Ridgewood, New Jersey, United States

Site Status

State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Countries

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United States Russia

Other Identifiers

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BWI-IIS-0143

Identifier Type: -

Identifier Source: org_study_id