Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02002923
• Other study ID #: BT_AF+PVI
• Status: Recruiting
• Phase: Phase 2
• First received: December 2, 2013
• Last updated: September 21, 2015
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Evgeny Pokushalov, MD, PhD
• Phone: +79139254858
• Email: e.pokushalov[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different treatment strategies, PVI only versus PVI plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed after follow-up of at least 1 years with the use of an implanted monitoring device (IMD).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Persistent and paroxysmal AF

Exclusion Criteria:

• congestive heart failure

• LV ejection fraction < 35%

• left atrial diameter > 60 mm

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein isolation
The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.

Drug:
• Botulinum Toxin
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).

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom of AF or other atrial arrhythmias		1 year	No
Secondary	serious adverse events		1 year	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site