Paroxysmal Atrial Fibrillation
Conditions
Brief summary
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
Detailed description
STUDY OBJECTIVE(S) -- To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. PRIMARY OBJECTIVE -- To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical). INDICATION(S) FOR USE -- Study devices will be used per approved Indications for Use for each geography. DEVICES / SYSTEM USED IN THE STUDY -- The study will include the following Boston Scientific Open-Irrigated Catheters in geographies where commercially approved for PAF ablation: * Blazer Open-Irrigated Ablation Catheter * IntellaNav Open-Irrigated Ablation Catheter * IntellaNav MiFi Open-Irrigated Ablation Catheter * IntellaTip MiFi Open-Irrigated Ablation Catheter * Rhythmia Mapping System Gen 1or Rhythmia HDx, equipped with Software 1.4 or any successive commercially approved versions. * IntellaMap Orion Catheter CONTROL DEVICE -- There are no control devices in this study STUDY DESIGN -- Prospective, non-randomized, multicenter (global), post approval clinical study (PAS). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for three years to complete the PAS design mandated from the FDA to collect post-market data for Boston Scientific Open-Irrigated Catheters and will be followed for three years. PLANNED NUMBER OF SUBJECTS -- The study will enroll 415 subjects. PLANNED NUMBER OF SITES / COUNTRIES -- The study is global (US, EU, Asia-Pacific) with 25-50 centers. A minimum of 50% of the sites will be selected from the US. No study site will be allowed to contribute more than 41 subjects (10% of the 415 enrollments requirement). FOLLOW-UP SCHEDULE -- Study Follow-ups are at: pre-discharge, 1 month (phone check), 3 months (blanking period), 6 months (phone check), 12 months, 24 months and 36 months. STUDY DURATION -- Study is expected to be completed in approximately five years (12-24 month enrollment period with three year follow-up). PARTICIPANT DURATION -- The study duration for each subject is expected to be approximately three years.
Interventions
DEVICEBoston Scientific Open Irrigated Ablation Catheters
The BSC Open-Irrigated catheters are designed to deliver RF energy to catheter tip electrode for cardiac ablation. The BSC OI catheters incorporate an open-irrigated cooling mechanism through a tip that is partitioned into two chambers. The proximal chamber circulates normal saline (0.9 %) within the tip to cool the proximal electrode and mitigate overheating while the distal chamber allows the fluid to flow through six irrigation holes into the patient's vasculature, thereby cooling the tip/tissue interface.
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. History of recurrent symptomatic Paroxysmal Atrial Fibrillation, defined as AFib that terminates spontaneously or with intervention within seven days of onset. Minimum documentation includes a physician's note indicating recurrent self-terminating Atrial Fibrillation AND one electrocardiographically documented AF episode within 6 months prior to enrollment. 2. Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with the Rhythmia Mapping system according to current international and local guidelines 3. Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with a Boston Scientific Open-Irrigated Ablation Catheter according to current international and local guidelines 4. Subjects who are willing and capable of providing informed consent 5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center 6. Subjects whose age is 20 years or above, or who are of legal age to give informed consent specific to state and national law.
Exclusion criteria
1. Subjects enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific 2. Subjects unable or unwilling to complete follow-up visits and examination for the duration of the study 3. Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical) 4. Subjects who have undergone any cardiac ablation within 30 days prior to enrollment 5. Unrecovered/unresolved Adverse Events from any previous invasive procedure 6. Life expectancy \<= three years per physician opinion 7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion) 8. Known cardiac thrombus within 60 days prior to enrollment 9. History of CVA, TIA or PE within 90 days prior to enrollment 10. Implanted pacemaker, ICD, or CRT leads within 90 days prior to enrollment 11. Implanted Left atrial appendage closure device prior to the index procedure 12. Prosthetic mitral or tricuspid heart valves (subjects with successful mitral valve repair allowed- annular ring constitutes repair) 13. Left atrial diameter greater than 5.5cm 14. Documented or suspected stenosis of any pulmonary veins. 15. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 16. Contraindication for anticoagulation 17. Clinically significant mitral valve regurgitation or stenosis per investigator discretion. 18. Any cardiac surgery ≤ 90 days from consent date. 19. Any electrocardiographically documented episode of Persistent AFib, defined as AFib lasting longer than 7 days from onset.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Safety Event-free at 12 Months Post Procedure | 12 months | This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below). Acute primary safety endpoint events are defined as the following: * Death * Myocardial infarction (MI) * Vagal Nerve Injury/Gastroparesis * Transient ischemic attack (TIA) * Stroke/Cerebrovascular accident (CVA) * Thromboembolism * Pericarditis * Cardiac tamponade/perforation * Pneumothorax * Vascular access complications * Pulmonary edema/heart failure * AV block Chronic primary safety endpoint events are defined as the following occurring through: 3 Months post-procedure 12 Months post-procedure * Atrial esophageal fistula * Pericardial effusion * Pulmonary vein stenosis (symptomatic and requiring intervention) |
| Number of Participants Effectiveness Event -Free at 12 Months Post Procedure | 12 Months | The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure. Primary effectiveness events are defined as: * Acute procedural failure * More than one repeat procedure during the blanking period (90 days post index procedure) * Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure * Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index procedure: * Repeat procedure * Cardioversion * Prescribed any AAD\* * AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Event Free Rate (Secondary) | 12 Months | The secondary effectiveness endpoint is defined as the event-free at 12 months post-procedure. Secondary effectiveness events are defined as: * Acute procedural failure * More than one repeat procedure during the blanking period (90 days post index procedure) * Documented symptomatic atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure * Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index procedure: * Repeat procedure * Cardioversion * Prescribed a higher dose of any AAD\* documented at baseline * Prescribed a new AAD\* not documented at baseline * AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence |
Countries
Germany, Japan, Monaco, South Korea, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATOROussama Wazni
The Cleveland Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 10.4 |
| Arrhythmia History Accessory Pathway | 9 Participants |
| Arrhythmia History Atrial Arrhythmia Occurred | 412 Participants |
| Arrhythmia History Atrial Arrhythmia Other | 16 Participants |
| Arrhythmia History Atrial Flutter | 103 Participants |
| Arrhythmia History Atrial Tachycardia | 25 Participants |
| Arrhythmia History AV Block 1 | 23 Participants |
| Arrhythmia History AV Block 2 | 1 Participants |
| Arrhythmia History Brady Arrhythmia Occurred | 108 Participants |
| Arrhythmia History Brady Arrhythmia Other | 2 Participants |
| Arrhythmia History Focal Atrial Tachycardia | 2 Participants |
| Arrhythmia History No Atrial Arrhythmias | 1 Participants |
| Arrhythmia History No Ventricular Arrhythmias | 357 Participants |
| Arrhythmia History ORT or AVRT | 5 Participants |
| Arrhythmia History Paroxysmal Atrial Fibrillation | 412 Participants |
| Arrhythmia History Sick Sinus Syndrome Chronotropic Incompetence | 10 Participants |
| Arrhythmia History Sinus arrest | 2 Participants |
| Arrhythmia History Sinus Bradycardia | 92 Participants |
| Arrhythmia History Sinus Node Dysfunction | 11 Participants |
| Arrhythmia History Ventricular Arrhythmia Occurred | 56 Participants |
| BMI | 29.4 kg/m^2 STANDARD_DEVIATION 7.2 |
| Cardiac Non-Arrhythmic Cardiac Disease Other | 15 Participants |
| Cardiac Non-Arrhythmic Cardiac thrombus | 5 Participants |
| Cardiac Non-Arrhythmic Cardiomyopathy | 34 Participants |
| Cardiac Non-Arrhythmic Cardiovascular Disease | 227 Participants |
| Cardiac Non-Arrhythmic Cerebrovascular Disease | 4 Participants |
| Cardiac Non-Arrhythmic Coagulopathy - Hypercoagulable State - Clotting Disorder | 11 Participants |
| Cardiac Non-Arrhythmic Congestive Heart Failure | 25 Participants |
| Cardiac Non-Arrhythmic Coronary Artery Disease | 74 Participants |
| Cardiac Non-Arrhythmic Hyperlipidemia | 119 Participants |
| Cardiac Non-Arrhythmic Hypertension | 159 Participants |
| Cardiac Non-Arrhythmic No history of cardiac disease | 186 Participants |
| Cardiac Non-Arrhythmic Other cardiovascular disease occurred | 194 Participants |
| Cardiac Non-Arrhythmic Peripheral Vascular Disease | 12 Participants |
| Cardiac Non-Arrhythmic Pulmonary Hypertension | 5 Participants |
| Cardiac Non-Arrhythmic Transient Ischemic Attack (TIA) CVA or PE | 19 Participants |
| Cardiac Non-Arrhythmic Valvular Disease | 21 Participants |
| Cardiac Procedure History Cardiac ablations | 28 Participants |
| Cardiac Procedure History Cardiac procedures | 77 Participants |
| Cardiac Procedure History None | 309 Participants |
| Height | 172.1 cm STANDARD_DEVIATION 10.2 |
| Noncardiac Comorbidities COPD | 24 Participants |
| Noncardiac Comorbidities Diabetes | 60 Participants |
| Noncardiac Comorbidities GI Bleeding | 12 Participants |
| Noncardiac Comorbidities Hepatic Disease | 7 Participants |
| Noncardiac Comorbidities Neurological Disease | 11 Participants |
| Noncardiac Comorbidities None | 211 Participants |
| Noncardiac Comorbidities Non-study hospitalization | 16 Participants |
| Noncardiac Comorbidities Other comorbidities | 97 Participants |
| Noncardiac Comorbidities Renal Disease | 17 Participants |
| Noncardiac Comorbidities Sleep Disordered Breathing | 76 Participants |
| Race/Ethnicity, Customized Race Asian | 95 Participants |
| Race/Ethnicity, Customized Race Black | 10 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 5 Participants |
| Race/Ethnicity, Customized Race Race Not Disclosed | 15 Participants |
| Race/Ethnicity, Customized Race White | 282 Participants |
| Region of Enrollment Germany | 24 participants |
| Region of Enrollment Japan | 82 participants |
| Region of Enrollment Monaco | 6 participants |
| Region of Enrollment South Korea | 21 participants |
| Region of Enrollment United Kingdom | 4 participants |
| Region of Enrollment United States | 278 participants |
| Resting Diastolic BP | 78.4 mmHG STANDARD_DEVIATION 12.6 |
| Resting Heart Rate | 68.4 bpm STANDARD_DEVIATION 15.1 |
| Resting Systolic BP | 132.6 mmHG STANDARD_DEVIATION 19.6 |
| Sex: Female, Male Female | 155 Participants |
| Sex: Female, Male Male | 259 Participants |
| Weight | 87.7 kg STANDARD_DEVIATION 24.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 383 |
| other Total, other adverse events | 46 / 383 |
| serious Total, serious adverse events | 135 / 383 |
Outcome results
None listed