ClinicalTrials.Veeva

Menu

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

M

Meshalkin Research Institute of Pathology of Circulation

Status and phase

Unknown
Phase 2

Conditions

Atrial Flutter

Treatments

Drug: Botulinum Toxin Type A injection
Procedure: radiofrequency ablation

Study type

Interventional

Funder types

NETWORK

Identifiers

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

RFA+BT injection
Active Comparator group
Description:
Transseptal puncture is performed by used standard endovascular approach. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
Treatment:
Drug: Botulinum Toxin Type A injection
Procedure: radiofrequency ablation
RFA
Active Comparator group
Description:
Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a flow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).
Treatment:
Procedure: radiofrequency ablation

Trial contacts and locations

1

Loading...

Central trial contact

Evgeny Pokushalov, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems