Atrial FibrillationPhase 3NCT00431834

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

A Phase 3 study testing Cardioblate System Surgical Ablation System and Surgical RF Ablation in people with Atrial Fibrillation, run by Medtronic Cardiovascular at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Cardioblate System Surgical Ablation System and Surgical RF Ablation
Type of treatment: Medical device, Surgery or procedure
How many people: 75 participants
Where: 15 sitesUnited States
Study dates: May 2007to Aug 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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)

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

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

Other trials in United States

About this study

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

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.

Conditions: Atrial Fibrillation
Being tested: Cardioblate System Surgical Ablation System, Surgical RF Ablation
Keywords: Permanent Atrial Fibrillation Surgical RF Ablation, Permanent Atrial Fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cardioblate System Surgical Ablation SystemDevice
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.
Surgical RF AblationProcedure or surgery
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months
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.
Measured: 30 days post procedure or hospital discharge

Secondary outcomes (2)

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
Measured: 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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Aug 2011

First posted6 Feb 2007 (estimated)
Study startMay 2007
Primary completionAug 2010
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00431834
Sponsor's protocol ID: CURE-AF/Permanent
Status last verified: Aug 2013
First submitted: 2 Feb 2007
Last updated: 27 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study
ClinicalTrials.gov ID: NCT00431834
Acronym / sponsor ID: CURE-AF/Permanent
Conditions: Atrial Fibrillation
Keywords: Permanent Atrial Fibrillation Surgical RF Ablation, Permanent Atrial Fibrillation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Aug 2010 (actual)
Study completion: Aug 2011 (actual)
First posted: 6 Feb 2007 (estimated)
Results: Posted 16 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:
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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cardioblate System Surgical Ablation SystemThis 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.	Device	–
Surgical RF AblationThis 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 or surgery	–

Primary outcome

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.
Time frame: 6 months
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
Time frame: 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.

2 secondary outcomes

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
Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure
Time frame: 6 months

Results and safety

Results posted to the registry on 16 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cardioblate Surgical Ablation System	75	62

Primary outcome: 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.

Time frame: 6 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cardioblate Surgical Ablation System n = 61
Value	37.7 (25.3 to 50.1)

Cardioblate Surgical Ablation System: binomial proportions: 37.7, p <0.0041, Fisher Exact

Population analysed: 75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.

Primary outcome: 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. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Cardioblate Surgical Ablation System n = 75
Value	5.3 (0 to 11.1)

Cardioblate Surgical Ablation System: binomial proportions: 5.3, p <0.0001, Fisher Exact

Population analysed: Entire study population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events reported from treatment through 6 month follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Completion Cohort	46 of 75 (61.3%)	62 of 75 (82.7%)	Not reported

Limitations and caveats (from the sponsor): * 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.)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24184028Damiano 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.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thoralf Sundt, MD principal investigator

The Mayo Clinic- Rochester

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cardioblate System Surgical Ablation System and Surgical RF Ablation in people with Atrial Fibrillation, run by Medtronic Cardiovascular at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00431834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.