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COMPLETED Phase 3

Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent

NCT00506493 · View on ClinicalTrials.gov ↗

Study Summary

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat persistent AF patients.

Conditions Studied

Interventions

  • DEVICE Cardioblate Surgical Ablation System
  • PROCEDURE Surgical RF Ablation

Study Locations (15)

California

  • East Bay Cardiovascular & Thoracic Associates — Concord
  • University of Southern California — Los Angeles
  • Eisenhower Medical Center — Palm Springs

Arizona

  • Southwest Heart and Lung — Phoenix

Florida

  • Cardiac Surgical Associates of Florida — St. Petersburg

Illinois

  • Northwestern Memorial Hospital — Chicago

Minnesota

  • Mayo/St. Mary's Hospital — Rochester

Missouri

  • Washington University School of Medicine — St Louis

New Jersey

  • Englewood Hospital and Medical Center — Englewood

New Mexico

  • New Mexico Heart Institute — Albuquerque

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2007-09
Est. Completion 2011-10
Phase Phase 3

Sponsor

Medtronic Cardiac Surgery

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00506493

The ClinicalTrials.gov registry entry for NCT00506493 describes a study currently listed as completed. It is categorized as Phase 3, 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 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Surgery, which has 7 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 Cardioblate Surgical Ablation System 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: NCT00506493 reports 15 study locations spanning 13 distinct geographic areas — top geographies include California, Arizona, Florida. 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 NCT00506493 about?

NCT00506493 is a clinical study titled "Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent". This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes p...

What is the current status of trial NCT00506493?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2007-09. Estimated completion is 2011-10.

What conditions does trial NCT00506493 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 NCT00506493?

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

Who is sponsoring clinical trial NCT00506493?

This trial is sponsored by Medtronic Cardiac Surgery, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00506493 being conducted?

This trial has 15 study locations across Arizona, California, Florida, Illinois, Minnesota. 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