Paroxysmal Atrial Fibrillation
Conditions
Brief summary
IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
Detailed description
Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.). Subjects will be followed at 7 days, 30 days, 3 months, 6 months and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF catheter ablation procedure.
Interventions
DEVICEIOWA Approach Endocardial Ablation System
Endocardial ablation using the IOWA Approach Endocardial Ablation System
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Endocardial Ablation System.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip. 2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents. 3. Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment. 4. Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure. 5. Subject has no contraindications to intraoperative transesophageal echocardiography; 6. Left ventricular ejection fraction ≥40% as documented by TTE within 12 months prior to the procedure. 7. Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators. 8. Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study.
Exclusion criteria
1. Patients on amiodarone at any time during the past 3 months prior to enrollment. 2. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 3. AF episodes lasting \> 7 days. 4. Previous ablation for AF. 5. Patient has a prosthetic heart valve. 6. Patient has a left atrial appendage device 7. Prior history of pericarditis or pericarditis within 3 months based on the TTE examination. 8. Subject is a woman of child bearing age 9. Prior history of rheumatic fever. 10. Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, Atrial septal defect ASD closure, left atrial appendage occlusion) 11. History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux 12. History of abnormal bleeding and/or clotting disorder. 13. Active malignancy or history of treated cancer within 24 months of enrollment. 14. Clinically significant infection or sepsis. 15. History of stroke or TIA within prior 6 months 16. New York heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment. 17. Body mass index \> 35. 18. Estimate glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 or has ever received dialysis. 19. History of untreated and serious hypotension, bradycardia or chronotropic incompetence. 20. Any of the following within 3 months of enrollment: * Major surgery except for the index procedure * Myocardial infarction * Unstable angina * Percutaneous coronary intervention (e.g., CABG or PTCA) * Sudden cardiac death event * Left atrial thrombus that has not resolved as shown by TEE or CT * Implant of pacemaker, ICD or CRT. 21. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant 22. History of pulmonary hypertension with Pulmonary systolic artery pressure \>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease. 23. Patients with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder). 24. Life expectancy less than one year. 25. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements. 26. History of blood clotting or bleeding abnormalities. 27. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin). 28. Enrolled in another cardiac clinical study that would interfere with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint for This Study is the Incidence of Early-onset (Within 7 Days of the PEF Ablation Procedure) Primary Adverse Events (AEs). | 7 days | The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PEF ablation procedure) primary adverse events (AEs). * Death * Myocardial infarction (MI) * Pulmonary vein (PV) stenosis† * Diaphragmatic paralysis * Atrio-esophageal fistula† * Transient Ischemic Attack (TIA) * Stroke/Cerebrovascular accident (CVA) Thromboembolism * Pericarditis requiring intervention (major) * Cardiac Tamponade/Perforation * Pneumothorax * Vascular Access Complications * Pulmonary edema * Hospitalization (initial and prolonged)\* * Heart block * Excludes hospitalization (initial & prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical). * Pulmonary vein (PV) stenosis or atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure shall be deemed a Primary AE. |
| Feasibility: Number of Patients With Pulmonary Vein Isolation | 1 Day (Acute) | Percentage of subjects achieving pulmonary vein isolation using the IOWA Approach Endocardial Ablation System. |
Countries
Czechia, France
Participant flow
Recruitment details
A total of 40 subjects consented and were treated.
Pre-assignment details
A total of 40 patients were enrolled (signed informed consent) and 40 subjects were treated at two (2) sites in Europe.
Participants by arm
| Arm | Count |
|---|---|
| IOWA Approach Endocardial Ablation Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation.
IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | IOWA Approach Endocardial Ablation | — |
|---|---|---|
| Age, Continuous | 58.2 Years STANDARD_DEVIATION 9.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 30 participants | — |
| Region of Enrollment France | 10 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 7 / 40 |
| serious Total, serious adverse events | 7 / 40 |
Outcome results
Primary
Feasibility: Number of Patients With Pulmonary Vein Isolation
Percentage of subjects achieving pulmonary vein isolation using the IOWA Approach Endocardial Ablation System.
Time frame: 1 Day (Acute)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IOWA Approach Endocardial Ablation | Feasibility: Number of Patients With Pulmonary Vein Isolation | 40 Participants |
Primary
The Primary Safety Endpoint for This Study is the Incidence of Early-onset (Within 7 Days of the PEF Ablation Procedure) Primary Adverse Events (AEs).
The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PEF ablation procedure) primary adverse events (AEs). * Death * Myocardial infarction (MI) * Pulmonary vein (PV) stenosis† * Diaphragmatic paralysis * Atrio-esophageal fistula† * Transient Ischemic Attack (TIA) * Stroke/Cerebrovascular accident (CVA) Thromboembolism * Pericarditis requiring intervention (major) * Cardiac Tamponade/Perforation * Pneumothorax * Vascular Access Complications * Pulmonary edema * Hospitalization (initial and prolonged)\* * Heart block * Excludes hospitalization (initial & prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical). * Pulmonary vein (PV) stenosis or atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure shall be deemed a Primary AE.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IOWA Approach Endocardial Ablation | The Primary Safety Endpoint for This Study is the Incidence of Early-onset (Within 7 Days of the PEF Ablation Procedure) Primary Adverse Events (AEs). | 2.5 percentage of participants |