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CompletedNCT00431834Updated Nov 27, 2013Results posted

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

A Phase 3 interventional study of Cardioblate System Surgical Ablation System and Surgical RF Ablation in Atrial Fibrillation, sponsored by Medtronic Cardiovascular. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-27.

Sponsored by Medtronic Cardiovascular · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Permanent Atrial Fibrillation Surgical RF Ablation
  • Permanent Atrial Fibrillation
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 75 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Medtronic Cardiovascular is the lead sponsor of 66 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Interventions

  • DeviceCardioblate 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.

  • ProcedureSurgical 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 30 days post procedure or hospital discharge

Secondary outcomes

  1. 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

  2. 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.

    Time frame: 6 months

07

Results

Posted Oct 16, 2013
Limitations and caveats
* Slow/delayed enrollment * Medical management of subjects by non-investigators leading to medication washout protocol deviations * Missing endpoint data (attrition) due to cohort demographics (old age, dementia, relocation, etc.)

Participant flow

A total of 91 subjects were consented to the study, of which 75 subjects received study treatment at 14 of the 15 investigational centers in the United States. The first subject was enrolled on May 22, 2007 and last patient enrolled on February 19, 2010.

Participant flow — Overall Study
MilestoneCardioblate Surgical Ablation System
Started75
Completed62
Not completed13
Withdrew: Withdrawal by subject7
Withdrew: Death3
Withdrew: Missed endpoint visit2
Withdrew: Lost to follow-up1

Outcome measures

PrimaryEfficacy 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.

Time frame:
6 months
Reported as:
Number · percentage of participants
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.
percentage of participantsCardioblate Surgical Ablation System
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.37.7 (25.3 to 50.1)
Statistical analysis
  • Cardioblate Surgical Ablation System · Fisher Exact · p = <0.0041 (The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percenter of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)) · Binomial proportions: 37.7
SecondaryEfficacy 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
Reported as:
Number · percentage of subjects
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
percentage of subjectsCardioblate Surgical Ablation System
Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months63.9
SecondarySafety 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.

Time frame:
6 months
Reported as:
Number · percentage of subjects
Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure
percentage of subjectsCardioblate Surgical Ablation System
Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure8.7
PrimarySafety 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.

Time frame:
30 days post procedure or hospital discharge
Reported as:
Number · Percentage of subjects
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Percentage of subjectsCardioblate Surgical Ablation System
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge5.3 (0 to 11.1)
Statistical analysis
  • Cardioblate Surgical Ablation System · Fisher Exact · p = <0.0001 (The percent of subjects following treatment, p, who experience any of the MAEs during the first 30 days following surgery, or hospital discharge, whichever is longer will be less than 23.6%.) · Binomial proportions: 5.3

Adverse events

Collected over Adverse events reported from treatment through 6 month follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study Completion Cohort—46/75 (61.3%)62/75 (82.7%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventStudy Completion Cohort
Pleural EffusionRespiratory, thoracic and mediastinal disorders14/75
Rhythms with potentially deleterious hemodynamic consequences requiring interventionCardiac disorders8/75
Atrioventricular Third Degree AV Heart BlockCardiac disorders6/75
Respiratory FailureRespiratory, thoracic and mediastinal disorders5/75
GI BleedGastrointestinal disorders3/75
HemmorrhageBlood and lymphatic system disorders3/75
PneumoniaRespiratory, thoracic and mediastinal disorders3/75
Pulmonary Insufficiency/FailureRespiratory, thoracic and mediastinal disorders3/75
Renal Insufficiency/Failure: Dialysis RequiredRenal and urinary disorders3/75
Sick Sinus SyndromeCardiac disorders3/75
Most frequent other events
Most frequent other events
EventStudy Completion Cohort
Pleural EffusionRespiratory, thoracic and mediastinal disorders23/75
AtelectasisRespiratory, thoracic and mediastinal disorders16/75
Renal Insufficiency/Failure: No Dialysis RequiredRenal and urinary disorders6/75
AnemiaBlood and lymphatic system disorders5/75
Congestive Heart FailureCardiac disorders4/75
Infection/SepsisInfections and infestations4/75
Pulmonary EdemaRespiratory, thoracic and mediastinal disorders4/75

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Entire Cohort
<=18 years0
Between 18 and 65 years17
>=65 years58
Age Continuous
Age Continuous(years)Entire Cohort
Mean70.9 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)Entire Cohort
Female33
Male42
Region of Enrollment
Region of Enrollment(participants)Entire Cohort
United States75
08

Study locations

15 sites
  • Southwest Heart and Lung
    Phoenix, Arizona 85260, United States
  • East Bay Cardiovascular & Thoracic Associates
    Concord, California 94520, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • Eisenhower Medical Center
    Palm Springs, California 92270, United States
  • Cardiac Surgical Associates of Florida
    St. Petersburg, Florida 33701, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • Mayo/St. Mary's Hospital
    Rochester, Minnesota 55902, United States
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
  • Englewood Hospital and Medical Center
    Englewood, New Jersey 07631, United States
  • New Mexico Heart Institute
    Albuquerque, New Mexico 87102, United States
  • Lenox Hill Hospital
    New York, New York 10075, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Hospital of University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Inova Fairfax
    Falls Church, Virginia 22042, United States
  • Aurora St. Luke's Medical Center
    Milwaukee, Wisconsin 53515, United States
09

References and documents

Publications

  • 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. PubMed 24184028 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00431834
Lead sponsor
Medtronic Cardiovascular
Responsible party
Sponsor
First posted
Feb 6, 2007
Start date
May 2007
Primary completion
Aug 2010
Completion
Aug 2011
Results posted
Oct 16, 2013
Last update
Nov 27, 2013

Study contacts

Thoralf Sundt, MD
principal investigator · The Mayo Clinic- Rochester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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