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

NCT02002962 | Unknown Phase 2 DMC

• 1 other identifier: BT_AFL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• number of paroxysms of atrial fibrillation

  1 year

Secondary Outcomes (2)

• AF burden

  1 year

• serious adverse events

  1 year

Study Arms (2)

RFA+BT injection

ACTIVE COMPARATOR

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).

Procedure: radiofrequency ablation; Drug: Botulinum Toxin Type A injection

RFA

ACTIVE COMPARATOR

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).

Procedure: radiofrequency ablation

Interventions

radiofrequency ablation PROCEDURE

RFA; RFA+BT injection

Botulinum Toxin Type A injection DRUG

RFA+BT injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• A history of atrial fibrillation
• Previous AF ablation procedure
• Congestive heart failure
• Left Ventricle ejection fraction less than 35%
• Unwillingness to participate

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

RECRUITING

Related Links

• State Research Institute of Circulation Pathology Official Site

MeSH Terms

Conditions

Atrial Flutter

Interventions

Radiofrequency Ablation; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Evgeny Pokushalov, MD, PhD

CONTACT

+79139254858; e.pokushalov@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

RU (1)