Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter

Phase 2UnknownNCT02002962

Meshalkin Research Institute of Pathology of Circulation60 enrolled

Overview

The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the radiofrequency ablation of atrial flutter.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atrial Flutter

Interventions

radiofrequency ablationPROCEDURE

Botulinum Toxin Type A injectionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * ECG documented paroxysmal or persistent AFL * No prior documented history of AF * Patient undergoing RFA of AFL. * No indication (other than AFL) for continued anticoagulation with warfarin. * No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device) Exclusion Criteria: * A history of atrial fibrillation * Previous AF ablation procedure * Congestive heart failure * Left Ventricle ejection fraction less than 35% * Unwillingness to participate

Locations (1)

State Research Institute of Circulation Pathology

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

number of paroxysms of atrial fibrillation

Time frame: 1 year

Secondary Outcomes

AF burden

Time frame: 1 year

serious adverse events

Time frame: 1 year

Central Contacts

Evgeny Pokushalov, MD, PhD

CONTACT

+79139254858 e.pokushalov@gmail.com

Data from ClinicalTrials.gov

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