Atrial Fibrillation
Conditions
Keywords
Permanent Atrial Fibrillation Surgical RF Ablation, Permanent Atrial Fibrillation
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 permanent AF patients.
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.
Sponsors
Medtronic Cardiovascular
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 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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. |
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 6 Months | 6 months | — |
| Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure | 6 months | Major Adverse Events included: 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 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.
Pre-assignment details
No additional wash out, run-in, or transition was utilized during this study.
Participants by arm
| Arm | Count |
|---|---|
| Entire Cohort All subjects enrolled and treated with the Cardioblate Surgical Ablation System | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Missed Endpoint Visit | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Entire Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 58 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age Continuous | 70.9 years STANDARD_DEVIATION 8.7 |
| 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 | 62 / 75 |
| serious Total, serious adverse events | 46 / 75 |
Outcome results
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.
Time frame: 6 months
Population: 75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardioblate 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 percentage of participants |
Comparison: The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%p-value: <0.0041Fisher Exact
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.
Time frame: 30 days post procedure or hospital discharge
Population: Entire study population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardioblate Surgical Ablation System | Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | 5.3 Percentage of subjects |
Comparison: The specific test hypothesis is as follows:~H0: p ≥ 23.6% Ha: p \< 23.6%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 6 Months
Time frame: 6 months
Population: 75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.
| 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 6 Months | 63.9 percentage of subjects |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardioblate Surgical Ablation System | Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure | 8.7 percentage of subjects |