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

Study:

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

Rationale:

n/a

Purpose:

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 Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Atrial Fibrillation Device: Cardioblate System Surgical Ablation System
Procedure: Surgical RF Ablation
Phase 3

Verified by Medtronic Cardiovascular August, 2013

Sponsored by: Medtronic Cardiovascular
Information provided by: Medtronic Cardiovascular
ClinicalTrials.gov identifier: NCT00431834

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Thoralf Sundt, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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