IRB Study Number 25-870
Status Recruiting
Location J Building - Sydell and Arnold Miller Family Pavilion
Institute Heart and Vascular Institute
Description
The purpose of this study is to learn more about the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation System and the OptiMap™ Catheter and OptiMap™ System in treating persistent atrial fibrillation (AFib). This study is for people who are experiencing symptoms, have not previously had an ablation procedure for atrial fibrillation, and have not improved with medication.
Pulsed field ablation is a procedure that uses short bursts of electrical energy to safely destroy small areas of abnormal heart tissue that may be causing AFib. Using a catheter called FARAWAVE™ NAV, this device ablates an area of your heart called the pulmonary veins. Ablation of the pulmonary veins is important because they are a common source of the abnormal electrical signals that trigger AFib. In some cases, AFib does not stop after ablating the pulmonary veins because other parts of the heart are also sending abnormal signals. By using the OptiMap Catheter and OptiMap System, your doctor may identify additional problem areas and treat them with pulsed field ablation using the FARAPOINT™ Catheter.
This study involves several medical devices. Most of them have been approved by the U.S. Food and Drug Administration (FDA) for regular medical use. One of the devices — the FARAPOINT™ Pulsed Field Ablation Catheter — is considered investigational, which means it has not yet been approved by the FDA for commercial use. Your participation in this study may help gather important information needed for future approval of this device.
Subjects will be asked to complete the following visits: Baseline (in-person), Procedure, Pre-discharge (in-person), Day 7 (remote/phone), Day 30 (remote/phone), Day 60 (in-person), Day 180 (remote/phone), Day 365 (in-person). Each in-person visit will last approximately 1 hour, and each remote/phone visit will last approximately 15-30 minutes. Testing at certain in-person visits will include procedures such as collection of Demographic data (such as age and gender), medical history, physical exam, blood tests (e.g., to check the number of red/white blood cells, electrolyte levels and kidney function), ECG (tracing of heart rhythm), imaging of the heart structure (like echocardiogram or CT scan), quality of life questionnaires and stroke questionnaire.
Inclusion Criteria
- ≥ 18 years of age, or older if required by local law
- Persistent AF Diagnosis and have symptomatic drug-refractory persistent AF, Ineffective, non-tolerated or contraindicated to at least one AAD (Class I or III) or diagnosis of Persistent AF is defined as an episode of continuous atrial fibrillation lasting 7 days or longer or lasting 48 hours to 7 days necessitating cardioversion for termination. It does not include Longstanding Persistent AF, which is defined as continuous AF greater than one year duration.
- 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
- Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
- Willing and capable of providing informed consent
Exclusion Criteria
- Any of the following atrial conditions
- Atrial size - LAD ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml
- Any prior atrial surgery
- Current atrial myxoma
- Current left atrial thrombus
- Pulmonary veins- Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
- History of sustained ventricular tachycardia or any ventricular fibrillation
- Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator discretion
- AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
- Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
- Implantable loop recorder, other than LUX-Dx
- Interatrial baffle, PFO or ASD 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
- Presence of any of the following or any of the following conditions at Baseline::
- mechanical prosthetic heart valve, ring, or repair through which the catheter must pass
- Moderate to severe mitral valve stenosis or mitral regurgitation
- Hypertrophic or amyloid cardiomyopathy
- Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
- Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 month
- Heart failure associated with NYHA Class III or IV
- Most recent documented LVEF < 40% within the previous 12 months
- Obesity-Body Mass Index (BMI) >45.0
- Known coagulopathy or bleeding disorder
- Anticoagulation Contraindication or unwillingness to use systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
- Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
- Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
- Active malignancy (other than squamous cell carcinoma)
- Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
- Known Active systemic infection
- Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour) as per the guidelines
- Predicted life expectancy less than one year per investigator medical judgement
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility
- Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
- Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
- CHA2DS2-VASc score ≥5
- Known allergic drug reaction to nitroglycerin (excluding hypotension)
- Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device
- Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- History of known congenital methemoglobin
- History of known G6PD deficiency
- Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
- Any documented history of Prinzmetal Angina or severe non-revascularizable coronary disease
- Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant
- Any other general health condition that, in the investigator’s medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
- Solid organ or hematologic transplant, or currently being evaluated for a transplant
- Any of the following events less than or equal to 90 days of the consent date:
- Myocardial infarction (MI), unstable angina or coronary intervention
- Any cardiac surgery
- Heart failure hospitalization
- Pericarditis or symptomatic pericardial effusion
- Gastrointestinal bleeding
- Stroke, TIA, or intracranial bleeding
- Any active non-neurologic thrombus and/or thromboembolic event
- Carotid stenting or endarterectomy
- Uncontrolled diabetes mellitus or a recorded HbA1c > 8.0%
