Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation
NCT ID: NCT01703247
Last Updated: 2012-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
264 participants
INTERVENTIONAL
2008-01-31
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PVI+LL
Circumferential 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.
Pulmonary vein isolation
Linear Lesion Ablation
PVI+GP
To 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).
Pulmonary vein isolation
Ganglionated plexi ablation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pulmonary vein isolation
Ganglionated plexi ablation
Linear Lesion Ablation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Evgeny Pokushalov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Research Institute of Circulation Pathology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
State Research Institute of CIrculation Pathology
Novosibirsk, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
State Research Institute of Circulation Pathology Official Site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GP-LL-AF
Identifier Type: -
Identifier Source: org_study_id