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NCT03057548 · ClinicalTrials.gov registry record · NA
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
A NA study of Persistent Atrial Fibrillation and Atrial Fibrillation Chronic, sponsored by Arash Aryana, MD.
- Completed
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 2
- Study locations
NCT03057548: Completed NA study of Persistent Atrial Fibrillation and Atrial Fibrillation Chronic, sponsored by Arash Aryana, MD.
NCT03057548 is a NA study of Persistent Atrial Fibrillation and Atrial Fibrillation Chronic that has completed, run by Arash Aryana, MD. The registered enrollment target is 110 participants, below the 1,253-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03057548, a NA study of Persistent Atrial Fibrillation and Atrial Fibrillation Chronic, has completed, sponsored by Arash Aryana, MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone. The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.
Primary Outcome
The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation.
Conditions Studied
Interventions
- PROCEDURE Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins
- PROCEDURE Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
Study Locations (2)
California
- Mercy General Hospital and Dignity Health Heart and Vascular Institute - Sacramento
Other
- Heart Center, Japan Red Cross Yokohama-city Bay Hospital - Yokohama
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2017-02-24 |
| Est. Completion | 2020-05-31 |
| Phase | NA |
What the finished NCT03057548 record still lists
NCT03057548 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,253-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Persistent Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins is the first listed.
NCT03057548 reports a single indexed study location in California, Other.
Frequently Asked Questions
What is clinical trial NCT03057548 about?
NCT03057548 is a clinical study titled "Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)". The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure ...
What is the current status of trial NCT03057548?
This trial is currently completed. It is a NA study. The enrollment target is 110 participants. The study started on 2017-02-24. Estimated completion is 2020-05-31.
What conditions does trial NCT03057548 study?
This clinical trial studies the following conditions: Persistent Atrial Fibrillation, Atrial Fibrillation Chronic.
What interventions are being tested in trial NCT03057548?
The interventions under investigation include: Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins (PROCEDURE), Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW (PROCEDURE).
Who is sponsoring clinical trial NCT03057548?
This trial is sponsored by Arash Aryana, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03057548 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03057548's enrollment target sits among peer trials
110 14th of 15 higher than 2 of 15 other Persistent Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Persistent Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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