Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
1 other identifier
interventional
160
2 countries
2
Brief Summary
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. Results were assessed with the use of an implanted monitoring device (IMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 6, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 23, 2015
September 1, 2015
2.5 years
December 6, 2013
September 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
1 year
Secondary Outcomes (1)
serious adverse events
1 year
Study Arms (2)
PVI+LL
ACTIVE COMPARATORCircumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
PVI+LL+BT injection
ACTIVE COMPARATORCircumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
Interventions
Eligibility Criteria
You may qualify if:
- Persistent and longstanding persistent AF
You may not qualify if:
- congestive heart failure
- LV ejection fraction \< 35%
- left atrial diameter \> 60 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Rochester
Rochester, New York, United States
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
December 11, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
September 23, 2015
Record last verified: 2015-09