Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioblate 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 or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months | Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours | 9 months |
| Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | Major Adverse Events were defined to include: 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 9 Months | 9 months | |
| Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure | Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury. |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
No additional wash out, run-in, or transition was utilized during this study. A subject was considered enrolled once treatment occurred.
A total of 90 subjects were consented into the study, of which 75 subjects received study treatment at 13 of the 15 investigational centers in the United States. The first subject was enrolled on September 18, 2007 and last patient enrolled on October 27, 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cardioblate Surgical Ablation System | 75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 9 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 | 63310 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Completion Cohort | 75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months | Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours | 75 subjects were enrolled, 14 subjects had no Holter assessment performed- 6 subjects died, 5 subjects withdrew participation, and 3 subjects completed endpoint follow-up without analyzable Holter data. | Posted | Number | percentage of subjects | 9 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury. | Posted | Number | percentage of subjects | 30 days post procedure or hospital discharge |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | percentage of subjects | 9 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure | Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury. | Posted | Number | percentage of subjects | 9 months |
|
|
Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made 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).
Not provided
| 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. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study. | 45 | 75 | 59 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemodynamic Instability | Cardiac disorders | Systematic Assessment |
| ||
| Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infection/Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrioventricular Third Degree AV Heart Block | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Insufficiency/Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Renal Insufficiency/Failure: Dialysis Required | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Insufficiency/Failure: No Dialysis Required | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhythms with Potentially Deleterious Hemodynamic Consequences Requiring Intervention | Cardiac disorders | Systematic Assessment |
| ||
| Shock | Cardiac disorders | Systematic Assessment |
| ||
| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Angina Presenting as SOB | Cardiac disorders | Systematic Assessment |
| ||
| Ascites with Paracentesis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial Fibrillation/Atrial Flutter/Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial tachycardia with dyspnea on exertion | Cardiac disorders | Systematic Assessment |
| ||
| Chest tube site wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Flu | General disorders | Systematic Assessment |
| ||
| Herniated lumbar disc | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Liver Failure | Endocrine disorders | Systematic Assessment |
| ||
| Liver Shock | Endocrine disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pain/discomfort on pacer site, right subclavian area | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rectal Bleeding | Renal and urinary disorders | Systematic Assessment |
| ||
| Sternal Dehiscence | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Upper Extremity Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hemodynamic Instability | Cardiac disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Renal Insufficiency/Failure: No Dialysis Required | Renal and urinary disorders | Systematic Assessment |
|
Not provided
| 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 |
Not provided
Not provided
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories |
|---|
|
|