CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 75 enrolled
Drug / intervention
Cardioblate System Surgical Ablation System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00431834
NCT00431834Phase 3Completed
CompareCT.gov

Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study

Medtronic Cardiovascular·interventional·Posted Feb 6, 2007·Updated Nov 27, 2013

In Brief

A Phase 3 clinical trial evaluating Cardioblate System Surgical Ablation System and Surgical RF Ablation for Atrial Fibrillation. Completed, enrolled 75 participants across 15 sites.

Detailed 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 permanent AF patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.4 years ago

Interventions

Cardioblate System Surgical Ablation Systemdevice

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with 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 grafts (CABG) procedures.

Surgical RF Ablationprocedure

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with 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 grafts (CABG) procedures.