atrial fibrillation atrial fibrillation
Conditions
Interventions
On the day of 
the procedure, all participants will receive a treatment called pulmonary vein isolation. Pulmonary veins are blood vessels that bring blood to the heart from the lungs. Ablation of the pulmonary vein
the patient agrees to participate in this research study or not. In this procedure, 
the doctor will use study devices that are commercially approved in the EU for the ablation of the pulmonary veins. 
If 
the patient 
is still in AFib after pulmonary vein ablation, a catheter called OptiMap Catheter will be inserted into 
the heart to collect abnormal electrical activity information from other areas of your heart and display those maps on the OptiMap System. If 
the patient is not in AFib, 
the doctor will attempt to temporarily induce AFib, using commercially approved devices to then collect those maps of abnormal electrical activity via the OptiMap Catheter.It is also possible that aft
the patient is still not in AFib or 
his/her AFib cannot be maintained long enough to be able to collect those maps. We expect this to happen to about 50 participants. When this happens, 
the patient will not receive any additional ablations. However, you will continue to receive all study related follow-up assessments for up to 12 months and be remotely monitored for 24 additional mon
Once 
a patient is in AFib, 
the patient will be randomized (flipping a coin) to a study group.If 
the patient is assigned to the control group, the same FARAWAVE NAV catheter used to abl
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age: = 18 years of age, or older if required by local law 2. Persistent AF Diagnosis: Have symptomatic drug-refractory persistent AF, confirmed by bothDocumentation, such as physician note, confirming the arrhythmia symptoms and persistent continuous AF for > 7 days and = 365 days Documentation, within 180 days of enrollment date of either: a) A 24-hour continuous ECG recording confirming continuous AF, OR b) Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart 3. Informed consent: Willing and capable of providing informed consent 4. Full participation: Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center 5. LUX-Dx: Willing to receive LUX-Dx insertable cardiac monitor (ICM) during the study or already has a LUX-Dx ICM that was inserted = 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions
Exclusion criteria
Exclusion criteria: 1. Any of the following atrial conditions: a) Atrial size: Left atrial anteroposterior diameter = 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (physician note or imaging) (Note: if both values are available, only the LA diameter will be used to confirm eligibility criteria)b) Prior atrial ablation: Any prior left atrial ablation c) Prior atrial surgery: Any prior atrial surgery d) Atrial myxoma: Current atrial myxoma e) LA thrombus: Current left atrial thrombus f) Pulmonary veins: Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) 2. Any of the following cardiovascular conditions: a) Ventricular arrhythmia: History of sustained ventricular tachycardia or any ventricular fibrillationb) Severe RV Dysfunction: Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator’s discretion c) Secondary AF: AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / noncardiac causes d) Cardiac devices and implants:• Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices • Implantable loop recorder, other than LUXDx • Interatrial baffle, patent foramen ovale closure device or atrial septal defect closure device or patch • Any left atrial appendage closure or occlusion device Note: Subject with a WATCHMAN device implanted > 90 days prior to enrollment, can be enrolled in the study.e) Valvular conditions: Presence of any of the following: • A mechanical or prosthetic heart valve, ring, or repair through which the catheter must pass; • Moderate to severe mitral valve stenosis • More than moderate mitral regurgitation f) Cardiomyopathy: Hypertrophic or amyloid cardiomyopathyg) Access issues: Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h) Anticipated cardiac surgery: Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months 3. Any of the following conditions at Baseline: a )Heart failure: Heart failure associated with NYHA Class III or IV b) Ejection fraction: Most recent documented LVEF < 40% within the previous 12 monthsc) Obesity: Body Mass Index (BMI) >45.0 d) Hematologic condition: Known coagulopathy or bleeding disorder e) Anticoagulation contraindication: Contraindication to, or unwillingness to use systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation f) Pregnancy: Women who are confirmed to be pregnant or lactating at the time of the ablation procedure g) Pulmonary disease: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen h) Malignancy: Active malignancy (other than squamous cell carcinoma)i) Gastrointestinal condition: Clinically significant gastrointestinal problems involving the esophagus or s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint (PSE) is the rate of ITT subjects in the PVI+EGF arm with one or more of the following device- or procedure-related Composite Adverse Events (CAEs) through 60 days following the Index Procedure with an onset date on or following the Index Procedure. Serious device or procedure-related CAEs related to any other ablation procedure that does not include commercially approved devices (regiondependent) such as the FARAPULSE PFA System, the OPAL HDx Mapping system or the OptiMap System will not be included in the analysis of the PSE. The primary effectiveness endpoint (PEE) is the rate of ITT subjects with Treatment Success in the PVI+EGF arm versus the PVI+PWA Control Arm, through the Day 365 Assessment, with the aim to demonstrate non-inferiority of the PVI+EGF Treatment Arm to the PVI+PWA Control Arm. Treatment success is defined as freedom from any of the conditions listed below, after the Day 60 Assessment, through the Day 365 follow-up visit: Arrhythmia: Occurrence of any detectable AF, AFL, or AT—captured by ICM and lasting =1 hour; by patient-triggered event recording on the ICM and lasting =30 seconds; or by 12-lead ECG and lasting =10 seconds Re-ablation: Any re-ablation for AF, AFL or AT Cardioversion: Any electrical cardioversion for AF, AFL or AT Anti-Arrhythmic Drug (AAD) Use: Use of a Non-Failed Class I / III AAD (drug or dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| The study has no Secondary Safety Endpoint. The secondary effectiveness endpoint is a test for superiority in Treatment Success between the Treatment Arm and the Control Arm. The test for superiority will only be conducted if the non-inferiority test for the PEE is passed and the result favors the Treatment Arm. The endpoint will be evaluated in all ITT subjects. | — |
Countries
Belgium, China, France, Germany, Netherlands, Spain, United States
Contacts
Public ContactY Lambrechts
Boston Scientific
Outcome results
None listed