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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT02002923
First received: December 2, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Procedure: Pulmonary vein isolation
Drug: Botulinum Toxin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Freedom of AF or other atrial arrhythmias [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serious adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PVI only 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.
Active Comparator: PVI+BT injection 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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent and paroxysmal AF

Exclusion Criteria:

  • congestive heart failure
  • LV ejection fraction < 35%
  • left atrial diameter > 60 mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002923

Contacts
Contact: Evgeny Pokushalov, MD, PhD +79139254858 e.pokushalov@gmail.com

Locations
Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD    +79139254858    E.Pokushalov@gmail.com   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
  More Information

Additional Information:
No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02002923     History of Changes
Other Study ID Numbers: BT_AF+PVI
Study First Received: December 2, 2013
Last Updated: December 2, 2013
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014