Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation

Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation

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).

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.

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.