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COMPLETED NA

STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation

NCT03118518 · View on ClinicalTrials.gov ↗

Study Summary

To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.

Interventions

  • DEVICE Cryoablation
  • DRUG Antiarrhythmic drug

Study Locations (20)

Florida

  • Tallahassee Research Institute Inc — Tallahassee
  • BayCare Medical Group Cardiology — Tampa

Michigan

  • University of Michigan Health System - University Hospital — Ann Arbor
  • Spectrum Health Hospitals — Grand Rapids

New Jersey

  • Hackensack University Medical Center — Hackensack
  • The Valley Hospital — Ridgewood

Ohio

  • Cleveland Clinic — Cleveland
  • Ohio State University — Columbus

Alabama

  • Grandview Medical Center — Birmingham

Alaska

  • Alaska Heart Institute — Anchorage

California

  • Hoag Hospital Newport Beach — Newport Beach

District of Columbia

  • MedStar Washington Hospital Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2017-06-23
Est. Completion 2020-06-25
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03118518

The ClinicalTrials.gov registry entry for NCT03118518 describes a study currently listed as completed. 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 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Ablation Solutions, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions — of which Cryoablation 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: NCT03118518 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, Michigan, New Jersey. 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 NCT03118518 about?

NCT03118518 is a clinical study titled "STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation". To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.

What is the current status of trial NCT03118518?

This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2017-06-23. Estimated completion is 2020-06-25.

What conditions does trial NCT03118518 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Fibrillation New Onset. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03118518?

The interventions under investigation include: Cryoablation (DEVICE), Antiarrhythmic drug (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03118518?

This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03118518 being conducted?

This trial has 20 study locations across Alabama, Alaska, California, District of Columbia, Florida. 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