Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation Surgical RF Ablation, Perisistent Atrial Fibrillation, Surgical Ablation
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 persistent AF patients.
Interventions
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.
Sponsors
Medtronic Cardiac Surgery
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 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 atrial ablation for AF, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 9 months | Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours |
| Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 9 months | Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
No additional wash out, run-in, or transition was utilized during this study. A subject was considered enrolled once treatment occurred.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Study Completion Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 57 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 70.1 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 59 / 75 |
| serious Total, serious adverse events | 45 / 75 |
Outcome results
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
Time frame: 9 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardioblate Surgical Ablation System | 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 | 42.6 percentage of subjects |
Comparison: The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%p-value: <0.01Fisher Exact
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.
Time frame: 30 days post procedure or hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardioblate Surgical Ablation System | Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | 6.7 percentage of subjects |
p-value: <0.0001Fisher Exact
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
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardioblate 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 9 Months | 67.2 percentage of subjects |
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.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardioblate Surgical Ablation System | Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure | 11.4 percentage of subjects |