Paroxysmal Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
Interventions
DEVICESJM Irrigated Cardiac Ablation System
Irrigated ablation catheter
DEVICEFDA approved Open Irrigated RF Ablation System
Irrigated ablation catheter
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Signed Patient Informed Consent Form * Able and willing to comply with all pre-, post-, and follow-up testing and requirements * Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation\* \[class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation\*, or intolerable side effects due to AAD * Subjects with symptomatic paroxysmal atrial fibrillation (PAF)\* * PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.
Exclusion criteria
* Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * Previous ablation for AF * History of any valvular cardiac surgical procedure * Coronary artery bypass grafting (CABG) procedure within the last six months * Awaiting cardiac transplantation or other cardiac surgery within the next 12 months * Left atrial thrombus * History of a documented thromboembolic event within the past one (1) year * Diagnosed atrial myxoma * An implanted implantable cardioverter defibrillator (ICD) * Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) * Acute illness or active systemic infection or sepsis * Unstable angina * Myocardial infarction within the previous two months * Left ventricular ejection fraction (LVEF) \<40% as determined by pre-procedure transthoracic echocardiogram (TTE) * History of blood clotting or bleeding abnormalities * Contraindication to anticoagulation (i.e. heparin or warfarin) * Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure * Life expectancy less than 12 months * Enrollment in an investigational study evaluating another device or drug * Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure * An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation * Presence of a condition that precludes vascular access * Left atrial size ≥ 50 mm as determined by pre-procedure TTE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of Entrance Block in the Pulmonary Veins | 20 minutes after initial isolation | — |
| Incidence of Adverse Events Included in the Pre-specified Composite | 7 days | Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications. |
| Incidence of Adverse Events Included in the Pre-specified Composite. | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period | 12 months | — |
| Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs | 12 months | Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs) |
Countries
Canada, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SJM Cardiac Ablation System SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter | 164 |
| FDA Approved Open Irriagated RF Ablation System FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter | 160 |
| Total | 324 |
Baseline characteristics
| Characteristic | SJM Cardiac Ablation System | FDA Approved Open Irriagated RF Ablation System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 68 Participants | 64 Participants | 132 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 96 Participants | 192 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 12.4 | 60.6 years STANDARD_DEVIATION 9.7 | 59.5 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Canada | 6 participants | 4 participants | 10 participants |
| Region of Enrollment Korea, Republic of | 9 participants | 7 participants | 16 participants |
| Region of Enrollment United States | 149 participants | 149 participants | 298 participants |
| Sex: Female, Male Female | 59 Participants | 66 Participants | 125 Participants |
| Sex: Female, Male Male | 105 Participants | 94 Participants | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 164 | 10 / 160 |
| serious Total, serious adverse events | 26 / 164 | 16 / 160 |
Outcome results
Primary
Confirmation of Entrance Block in the Pulmonary Veins
Time frame: 20 minutes after initial isolation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Cardiac Ablation System | Confirmation of Entrance Block in the Pulmonary Veins | 159 participants |
| FDA Approved Open Irriagated RF Ablation System | Confirmation of Entrance Block in the Pulmonary Veins | 157 participants |
Primary
Incidence of Adverse Events Included in the Pre-specified Composite
Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Cardiac Ablation System | Incidence of Adverse Events Included in the Pre-specified Composite | 7 participants |
| FDA Approved Open Irriagated RF Ablation System | Incidence of Adverse Events Included in the Pre-specified Composite | 6 participants |
Primary
Incidence of Adverse Events Included in the Pre-specified Composite.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Cardiac Ablation System | Incidence of Adverse Events Included in the Pre-specified Composite. | 12 participants |
| FDA Approved Open Irriagated RF Ablation System | Incidence of Adverse Events Included in the Pre-specified Composite. | 13 participants |
Secondary
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Cardiac Ablation System | Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period | 116 participants |
| FDA Approved Open Irriagated RF Ablation System | Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period | 119 participants |
Secondary
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Cardiac Ablation System | Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs | 40 participants |
| FDA Approved Open Irriagated RF Ablation System | Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs | 26 participants |