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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioblate System Surgical Ablation System | Device | 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 Ablation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Thoralf Sundt, MD | The Mayo Clinic- Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Heart and Lung | Phoenix | Arizona | 85260 | United States | ||
| East Bay Cardiovascular & Thoracic Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24184028 | Derived | 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. |
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No additional wash out, run-in, or transition was utilized during this study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardioblate Surgical Ablation System | 75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 months |
| 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 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Cohort | All subjects enrolled and treated with the Cardioblate Surgical Ablation System |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| 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 | 75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data. | Posted | Number | percentage of subjects | 6 months |
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| 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. | All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis. | Posted | Number | percentage of subjects | 6 months |
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| 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. | Entire study population. | Posted | Number | 95% Confidence Interval | Percentage of subjects | 30 days post procedure or hospital discharge |
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Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Completion Cohort | 75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up. | 46 | 75 | 62 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
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| Hemmorrhage | Blood and lymphatic system disorders | Systematic Assessment |
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| Infection/Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atrioventricular Third Degree AV Heart Block | Cardiac disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Insufficiency/Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal Insufficiency/Failure: Dialysis Required | Renal and urinary disorders | Systematic Assessment |
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| Renal Insufficiency/Failure: No Dialysis Required | Renal and urinary disorders | Systematic Assessment |
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| Respirator Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhythms with potentially deleterious hemodynamic consequences requiring intervention | Cardiac disorders | Systematic Assessment |
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| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Aystole | Cardiac disorders | Systematic Assessment |
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| Cerebellar Hemorrhage | Nervous system disorders | Systematic Assessment |
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| Hematoma- rt psoas muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Entrapped SWAN-GANZ Catheter | Vascular disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Damaged PPM Lead | Cardiac disorders | Systematic Assessment |
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| Worstening Heart Failure | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Ventricular Septal Defect | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia/Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
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| Femoral Atery Psuedoaneurysm | Vascular disorders | Systematic Assessment |
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| Increased Blood Pressure | Vascular disorders | Systematic Assessment |
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| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Failure to Thrive | Gastrointestinal disorders | Systematic Assessment |
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| Post-op ileus/small bowel obstruction abdominal hernia repair | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Infection/Sepsis | Infections and infestations | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal Insufficiency/Failure: No Dialysis Required | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Lawman | Medtronic, Inc. | 763-514-9809 | kristin.j.lawman@medtronic.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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