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

Sponsored by:	Medtronic Cardiac Surgery
Information provided by:	Medtronic Cardiac Surgery
ClinicalTrials.gov Identifier:	NCT00506493

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 persistent AF patients.

Condition	Intervention	Phase
Atrial Fibrillation	Device: Surgical RF Ablation utilizing the Cardioblate System	Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Persistent Study

Further study details as provided by Medtronic Cardiac Surgery:

Primary Outcome Measures:

Efficacy Endpoint: The percent of patients off Class I or III antiarrhythmic drugs and out of AF as determined by 24 hour Holter recording at 9 months [ Time Frame: 9 months ]
Safety Endpoint: Composite acute major adverse event rate, within 30 days post-procedure or hospital discharge [ Time Frame: 30 days post procedure or hospital discharge ]

Secondary Outcome Measures:

Efficacy Endpoints: The percent of patients out of AF, regardless of antiarrhythmic drug status, as determined by a 24 hour Holter recording at 9 months [ Time Frame: 9 months ]
Safety Endpoints: Composite 9-month major adverse event rate, post-procedure [ Time Frame: 9 months ]

Estimated Enrollment:	75
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2012

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: Characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days.
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
Greater than or equal to 18 years of age
Able and willing to comply with study requirements by signing a consent form
Must be able to take the anticoagulant warfarin (Coumadin)

Exclusion Criteria:

Wolff-Parkinson-White syndrome
NYHA Class = IV
Left ventricular ejection fraction ≤ 30%
Need for emergent cardiac surgery (i.e. cardiogenic shock)
Previous atrial ablation for AF, AV-nodal ablation, or surgical Maze procedure
Contraindication for anticoagulation therapy
Left atrial diameter > 7.0 cm
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Renal failure requiring dialysis or hepatic failure
Life expectancy of less than one year
Pregnancy or desire to be pregnant within 12 months of the study treatment.
Current diagnosis of active systemic infection
Documented MI 6 weeks prior to study enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506493

Contacts

Contact: Kathy Fahey	763-514-6645	kathy.fahey@medtronic.com
Contact: Eric Vang	763-514-6655	eric.vang@medtronic.com

Locations

United States, Arizona
Southwest Heart and Lung	Recruiting
Phoenix, Arizona, United States
Contact: JoAnne Saczynski, RN, MSN, CRC 408.323.3390 jsaczynski@shc.org
Contact: Martha Hatifield, RN, BSN, CCRC 408.323.3833 MHatfield@SHC.org
Principal Investigator: Michael Caskey, MD
Sub-Investigator: Kenneth Ashton
United States, California
University of Southern California	Recruiting
Los Angeles, California, United States, 90033
Contact: Becky Lopez, RN 323-442-6226 bmlopez@surgery.usc.edu
Principal Investigator: Vaughn A Starnes, MD
Sub-Investigator: Mark J Cunningham, MD
Sub-Investigator: Craig J. Baker, MD
Eisenhower Medical Center	Recruiting
Palm Springs, California, United States, 92270
Contact: Walter DeSha 760-568-4330 wdesha@emc.org
Contact: William Boyle 760.568.4330 wboyle@emc.org
Principal Investigator: Surin Mitruka, MD
United States, Illinois
Northwestern Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin, , RN, BSN, CCRC (312) 695-4067
Contact: Jane Kruse, RN, BSN 312.695.4665 jkruse@nmh.org
Sub-Investigator: Patrick M McCarthy, MD
Principal Investigator: Richard Lee, MD, MBA
United States, Minnesota
Mayo/St. Mary's Hospital	Recruiting
Rochester, Minnesota, United States, 55902
Contact: Deborah A Rolbiecki 507-266-8044 rolbiecki.deborah@mayo.edu
Principal Investigator: Thoralf Sundt, M.D
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States
Contact: Marcie Bailey, RN, MSN 314-747-1930 baileym@wustl.edu
Principal Investigator: Ralph Damiano, MD
United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States
Contact: Denise Kosty Sweeny 216-444-0758 sweened2@ccf.org
Contact: Pam Lackner (216) 445-4337 LACKNEP@ccf.org
Principal Investigator: A. Marc Gillinov, MD
Sub-Investigator: Tomislav Mihaljevic, MD
Sub-Investigator: Lars Svensson, MD
Sub-Investigator: Eric Roselli, MD
Sub-Investigator: Jose Navia, MD
Sub-Investigator: Gosta Pettersson, MD
Sub-Investigator: Nicholas Smedira, MD
United States, Pennsylvania
Hospital of University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States
Contact: Deb Dougherty, RN, BSN, CCRC 215-662-4806 deb.dougherty@uphs.upenn.edu
Principal Investigator: Michael Acker, MD
United States, Virginia
Inova Fairfax	Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Vivianna Aristizabal 703-776-2645 var@rxtrialsinc.com
Contact: Kathy Pancoe, RN 703.776.2645 kep@rxtrialsinc.com
Principal Investigator: Niv Ad, MD
United States, Wisconsin
Aurora St. Luke's Medical Center	Recruiting
Milwaukee, Wisconsin, United States, 53515
Contact: Jennifer Cooper, RN, CNOR 414-385-2504 jennifer.cooper@aurora.org
Principal Investigator: David C Kress, MD

Sponsors and Collaborators

Medtronic Cardiac Surgery

Investigators

Principal Investigator:	Ralph Damiano, MD	Washington University School of Medicine
Principal Investigator:	A. Marc Gillinov, MD	The Cleveland Clinic

More Information

Study ID Numbers:	CURE-AF/Persistent
Study First Received:	July 22, 2007
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00506493
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Surgery:

Persistent Atrial Fibrillation Surgical RF Ablation
Perisistent Atrial Fibrillation
Surgical Ablation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009