Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation
Ganglionated Plexi Ablation vs Linear Ablation in Patients Undergoing Pulmonary Vein Isolation for Persistent/Longstanding Persistent Atrial Fibrillation: A Randomized Comparison
1 other identifier
interventional
264
1 country
1
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) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF. Results were assessed after follow-up of at least 3 years 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 Jan 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2012
CompletedFirst Posted
Study publicly available on registry
October 10, 2012
CompletedOctober 10, 2012
October 1, 2012
1 year
October 5, 2012
October 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
3 years
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+GP
ACTIVE COMPARATORTo accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).
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 (1)
State Research Institute of CIrculation Pathology
Novosibirsk, 630055, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeny Pokushalov, MD, PhD
State Research Institute of Circulation Pathology
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
October 5, 2012
First Posted
October 10, 2012
Study Start
January 1, 2008
Primary Completion
January 1, 2009
Study Completion
May 1, 2009
Last Updated
October 10, 2012
Record last verified: 2012-10