Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter to Prevent Post-procedural Atrial Fibrillation
Overview
- Phase
- Phase 2
- Intervention
- radiofrequency ablation
- Conditions
- Atrial Flutter
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- number of paroxysms of atrial fibrillation
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
RFA+BT injection
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).
Intervention: radiofrequency ablation
RFA+BT injection
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).
Intervention: Botulinum Toxin Type A injection
RFA
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).
Intervention: radiofrequency ablation
Outcomes
Primary Outcomes
number of paroxysms of atrial fibrillation
Time Frame: 1 year
Secondary Outcomes
- serious adverse events(1 year)
- AF burden(1 year)