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NCT06223789 · ClinicalTrials.gov registry record · NA
VOLT-AF IDE Clinical Study
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 392
- Enrollment target
NCT06223789: Completed NA study, sponsored by Abbott Medical Devices.
NCT06223789 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 392 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06223789, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 392 participants
- Enrollment target
Study Summary
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.
Primary Outcome
Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications / major bleeding events * Device and/or procedure related cardiovascular
Interventions
- DEVICE Pulsed Field Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2025-10-03 |
| Phase | NA |
What the finished NCT06223789 record still lists
NCT06223789 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Pulsed Field Ablation is the first listed.
NCT06223789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06223789 about?
NCT06223789 is a clinical study titled "VOLT-AF IDE Clinical Study". This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of re...
What is the current status of trial NCT06223789?
This trial is currently completed. It is a NA study. The enrollment target is 392 participants. The study started on 2024-04-03. Estimated completion is 2025-10-03.
What interventions are being tested in trial NCT06223789?
The interventions under investigation include: Pulsed Field Ablation (DEVICE).
Who is sponsoring clinical trial NCT06223789?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06223789's enrollment target sits among peer trials
392 269th of 2000 higher than 1,732 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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