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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431834
• Other study ID #: CURE-AF/Permanent
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2007
• Last updated: November 3, 2013
• Start date: May 2007
• Est. completion date: August 2011

Study information

• Verified date: August 2013
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines.

2. Concomitant indication (other than AF) for open-heart surgery for one or more of the following:

• Mitral valve repair or replacement

• Aortic valve repair or replacement

• Tricuspid valve repair or replacement

• Atrial septal defect (ASD) repair

• Patent foramen ovale (PFO) closure

• Coronary artery bypass procedures

3. Greater than or equal to 18 years of age

4. Able and willing to comply with study requirements by signing a consent form

5. Must be able to take the anticoagulant warfarin (Coumadin)

Exclusion Criteria:

1. Wolff-Parkinson-White syndrome

2. NYHA Class = IV

3. Left ventricular ejection fraction = 30%

4. Need for emergent cardiac surgery (i.e. cardiogenic shock)

5. Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze procedure

6. Contraindication for anticoagulation therapy

7. Left atrial diameter > 7.0 cm

8. Preoperative need for an intra-aortic balloon pump or intravenous inotropes

9. Renal failure requiring dialysis or hepatic failure

10. Life expectancy of less than one year

11. Pregnancy or desire to be pregnant within 12 months of the study treatment.

12. Current diagnosis of active systemic infection

13. Documented MI 6 weeks prior to study enrollment

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Cardioblate System Surgical Ablation System
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.

Procedure:
• Surgical RF Ablation
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.

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	East Bay Cardiovascular & Thoracic Associates	Concord	California
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Inova Fairfax	Falls Church	Virginia
United States	University of Southern California	Los Angeles	California
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Lenox Hill Hospital	New York	New York
United States	Eisenhower Medical Center	Palm Springs	California
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania
United States	Southwest Heart and Lung	Phoenix	Arizona
United States	Mayo/St. Mary's Hospital	Rochester	Minnesota
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Cardiac Surgical Associates of Florida	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.	Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.	6 months	No
Primary	Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge	Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.	30 days post procedure or hospital discharge	Yes
Secondary	Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months		6 months	No
Secondary	Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure	Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.	6 months	Yes