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

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

NCT02002962

BT_AFL

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

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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