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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cardioblate System Surgical Ablation System
Surgical RF Ablation
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Permanent Atrial Fibrillation Surgical RF Ablation, Permanent Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Heart and Lung
  • East Bay Cardiovascular & Thoracic Associates
  • University of Southern California
  • Eisenhower Medical Center
  • Cardiac Surgical Associates of Florida
  • Northwestern Memorial Hospital
  • Mayo/St. Mary's Hospital
  • Washington University School of Medicine
  • Englewood Hospital and Medical Center
  • New Mexico Heart Institute
  • Lenox Hill Hospital
  • Cleveland Clinic Foundation
  • Hospital of University of Pennsylvania
  • Inova Fairfax
  • Aurora St. Luke's Medical Center

Outcomes

Primary Outcome Measures

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.
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.

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 6 Months
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.

Full Information

First Posted
February 2, 2007
Last Updated
November 3, 2013
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00431834
Brief Title
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
Official Title
Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Permanent Atrial Fibrillation Surgical RF Ablation, Permanent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cardioblate System Surgical Ablation System
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical RF Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.
Time Frame
6 months
Title
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Description
Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
Time Frame
30 days post procedure or hospital discharge
Secondary Outcome Measure Information:
Title
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
Time Frame
6 months
Title
Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure
Description
Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines. 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 ablation for atrial fibrillation, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thoralf Sundt, MD
Organizational Affiliation
The Mayo Clinic- Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Heart and Lung
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
East Bay Cardiovascular & Thoracic Associates
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Eisenhower Medical Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Cardiac Surgical Associates of Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Mayo/St. Mary's Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospital of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Inova Fairfax
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53515
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24184028
Citation
Damiano RJ Jr, Badhwar V, Acker MA, Veeragandham RS, Kress DC, Robertson JO, Sundt TM. The CURE-AF trial: a prospective, multicenter trial of irrigated radiofrequency ablation for the treatment of persistent atrial fibrillation during concomitant cardiac surgery. Heart Rhythm. 2014 Jan;11(1):39-45. doi: 10.1016/j.hrthm.2013.10.004. Epub 2013 Oct 31.
Results Reference
derived

Learn more about this trial

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

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