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NCT00506493 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Atrial Fibrillation, sponsored by Medtronic Cardiac Surgery.

Completed
Registry status
Phase 3
Development phase
75
Enrollment target
15
Study locations

NCT00506493 is a Phase 3 study of Atrial Fibrillation that has completed, run by Medtronic Cardiac Surgery. The registered enrollment target is 75 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 13 states.

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The verdict

NCT00506493, a Phase 3 study of Atrial Fibrillation, has completed, sponsored by Medtronic Cardiac Surgery.

COMPLETED
Registry status
Phase 3
Development phase
75 participants
Enrollment target
15
Study locations

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

Atrial Fibrillation

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, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The listed sponsor is Medtronic Cardiac Surgery, which has 7 total studies on file at ClinicalTrials.gov.

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.

NCT00506493 reports 15 study locations spanning 13 distinct geographic areas - top geographies include California, Arizona, Florida.

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.

What interventions are being tested in trial NCT00506493?

The interventions under investigation include: Cardioblate Surgical Ablation System (DEVICE), Surgical RF Ablation (PROCEDURE).

Who is sponsoring clinical trial NCT00506493?

This trial is sponsored by Medtronic Cardiac Surgery, which has 7 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.