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RECRUITING NA

CardioFocus HeartLight Post-Approval Study

NCT03168659 · View on ClinicalTrials.gov ↗

Study Summary

This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.

Conditions Studied

Interventions

  • PROCEDURE Ablation
  • DEVICE HeartLight

Study Locations (4)

Arizona

  • University of Arizona Sarver HeartCenter — Tucson

Illinois

  • University of Illinois — Chicago

New York

  • Mount Sinai Hospital — New York

Virginia

  • University Of Virginia Health System — Charlottesville

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2017-06-16
Est. Completion 2028-10
Phase NA

Sponsor

CardioFocus

2 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03168659

The ClinicalTrials.gov registry entry for NCT03168659 describes a study currently listed as 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 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CardioFocus, which has 2 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 2 interventions — of which Ablation 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: NCT03168659 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Arizona, Illinois, New York. 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 NCT03168659 about?

NCT03168659 is a clinical study titled "CardioFocus HeartLight Post-Approval Study". This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.

What is the current status of trial NCT03168659?

This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2017-06-16. Estimated completion is 2028-10.

What conditions does trial NCT03168659 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 NCT03168659?

The interventions under investigation include: Ablation (PROCEDURE), HeartLight (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03168659?

This trial is sponsored by CardioFocus, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03168659 being conducted?

This trial has 4 study locations across Arizona, Illinois, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial