Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
NCT ID: NCT03295422
Last Updated: 2020-11-19
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
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-08-25
2021-12-31
Brief Summary
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Detailed Description
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This randomized controlled trial will compare two radiofrequency ablation strategies, PVI alone and pulmonary vein isolation plus left posterior atrial wall (LPAW) isolation in individuals with persistent AF. Both strategies are currently used to treat persistent AF, but no randomized controlled trial ahs been conducted to investigate which strategy is more efficacious.
Two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency ablation procedure for AF. For group 1, a series of radiofrequency applications will be delivered around both sets of pulmonary veins. For group 2, a series of radiofrequency applications will be delivered around both sets of pulmonary veins and along a roof and low posterior line of the left atrial wall.
All subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. If indicated, antiarrhythmic drugs will be discontinued. For the first month, subjects will receive a continuously recording electrocardiogram heart card to monitor for AF, and then two-week ambulatory monitors at 3 months and one year post ablation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RF ablation PVI alone
RF catheter ablation of pulmonary veins alone
RF ablation PVI alone
A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.
RF ablation PVI plus LPAW
RF catheter ablation PVI plus left atrial posterior wall
RF ablation PVI plus LPAW
A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.
Interventions
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RF ablation PVI alone
A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.
RF ablation PVI plus LPAW
A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Refractory to at least one antiarrhythmic agent.
3. Undergoing ablation for the first time.
Exclusion Criteria
2. Sustained atrial fibrillation lasting more than 3 years
3. Left atrial diameter of 60 mm or greater
18 Years
ALL
No
Sponsors
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Sequoia Hospital
OTHER
Responsible Party
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Christopher E. Woods, MD, PhD
Study Principal Investigator
Principal Investigators
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Christopher E Woods, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dignity Health, Sequoia Hospital
Locations
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Dignity Health, Sequoia Hospital
Redwood City, California, United States
Countries
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Central Contacts
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Facility Contacts
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Christopher E Woods, MD, PhD
Role: primary
Ann Campbell, RN, MBA
Role: backup
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Persistent AF Study 01
Identifier Type: -
Identifier Source: org_study_id