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Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
NCT06099730 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
Conditions Studied
Interventions
- DEVICE Pulsed Field Ablation (PFA)
Study Locations (7)
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
New York
- Mount Sinai Hospital — New York
- Montefiore Medical Center — New York
Arkansas
- St. Bernard's Heart and Vascular Center — Jonesboro
Ohio
- Cleveland Clinic — Cleveland
Texas
- Texas Cardiac Arrhythmia Institute/Research Foundation — Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2023-12-14 |
| Est. Completion | 2026-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06099730
The ClinicalTrials.gov registry entry for NCT06099730 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which Pulsed Field Ablation (PFA) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06099730 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Massachusetts, New York, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06099730 about?
NCT06099730 is a clinical study titled "Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF". The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation w...
What is the current status of trial NCT06099730?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2023-12-14. Estimated completion is 2026-11.
What conditions does trial NCT06099730 study?
This clinical trial studies the following conditions: Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06099730?
The interventions under investigation include: Pulsed Field Ablation (PFA) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06099730?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06099730 being conducted?
This trial has 7 study locations across Arkansas, Massachusetts, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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