A Prospective Open-Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients with Paroxysmal Atrial Fibrillation.

Recruiting

Conditions: irregular heartbeat
Paroxysmal Atrial Fibrillation
10007521

Registration Number: NL-OMON51524

Lead Sponsor: FARAPULSE, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Study subjects are required to meet all the following inclusion criteria to
participate in this study:
1. Patients with PAF that meets all the following criteria:
a. Paroxysmal: AF that terminates spontaneously or with intervention within 7
days of onset.
b. Frequency:
i. Physician documentation of recurrent PAF (two or more episodes) within 6
months, AND
ii. At least one (1) documented episode by an approved recording device within
12 months of enrollment.
c. Drug Failed atrial fibrillation drug (AAD) treatment, meaning therapeutic
failure of at least one AAD (class I - IV) for efficacy and / or intolerance.
2.Patients who are >= 18 and <= 80 years of age on the day of enrollment.
3. Patient participation requirements:
a. Is willing and capable of providing Informed Consent to undergo study
procedures.
b. Is willing to participate in all examinations and follow-up visits and tests
associated with this clinical study.

Exclusion Criteria

Subjects will be excluded from participating in this study if they meet any one
of the following exclusion criteria:
1. Atrial fibrillation that is any of the following:
a. Persistent (both early and longstanding) by diagnosis or continuous duration
> 7 days
b. Secondary to electrolyte imbalance, thyroid disease, alcohol or other
reversible / non-cardiac causes
c. Requires four (4) or more direct-current cardioversions in the preceding 12
months
2. Any of the following atrial conditions:
a. Left atrial anteroposterior diameter >= 5.5 cm
b. Any prior atrial endocardial or epicardial ablation procedure, other than
right sided cavotricuspid isthmus ablation or for right sided SVT
c. Any prior atrial surgery
d. Interatrial septal patch or interatrial shunt
e. Atrial myxoma
f. Current LA thrombus
g. LA appendage closure, device or occlusion
h. Any PV abnormality, stenosis or stenting (common and middle PVs are
admissible)
3. At any time, one or more of the following cardiovascular procedures,
implants or conditions:
a. Sustained ventricular tachycardia or any ventricular fibrillation
b. Hemodynamically significant valvular disease
c. Clinically significant hypertrophic cardiomyopathy
d. Any prosthetic heart valve, ring or repair including balloon aortic
valvuloplasty
e. Contraindication to femoral venous access
4. Any of the following procedures, implants or conditions:
a. At baseline:
i. Congestive heart failure with New York Heart Association (NYHA) Class III or
IV
ii. Left ventricular ejection fraction (LVEF) < 35%
iii. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP
measurements at baseline assessment)
iv. Implantable loop recorder or insertable cardiac monitor
b. Within the 3 months preceding the Consent Date:
i. Myocardial infarction
ii. Unstable angina
iii. Percutaneous coronary intervention
iv. Implantation of a pacemaker, cardioverter defibrillator or cardiac
resynchronization therapy device
v. Heart failure hospitalization
vi. Treatment with amiodarone
vii. Pericarditis or symptomatic pericardial effusion
viii. Gastrointestinal bleeding
c. Within the 6 months preceding the Consent Date:
i. Heart surgery
ii. Stroke, TIA or intracranial bleeding
iii. Any thromboembolic event
iv. Carotid stenting or endarterectomy
5. Diagnosed disorder of blood clotting or bleeding diathesis
6. Contraindication to, or unwillingness to use, systemic anticoagulation
7. Patient who is not on anticoagulation therapy for at least 3 weeks prior to
the ablation procedure
8. Women of childbearing potential who are pregnant, lactating, not using birth
control or planning to become pregnant during the anticipated study period
9. Medical conditions that would prevent participation in the study, interfere
with assessment or therapy, significantly raise the risk of study
participation, or confound data or its interpretation, including but not
limited to:
a. Body mass index (BMI) > 45.0
b. Solid organ or hematologic transplant, or currently being evaluated for an
organ transplant
c. Severe lung disease, pulmonary hypertension, or any lung disease associated
with chronic abnormal blood gases or requiring supplemental oxygen
d. Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30
mL/mi

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety endpoint is the Composite Safety Endpoint (CSE) defined as<br /><br>the proportion of Safety Subjects with one or more of the<br /><br>following device- or procedure-related SAEs as adjudicated by the CEC based on<br /><br>protocol definitions.<br /><br><br /><br>Early onset (within 7 days of an index or Rescheduled Index procedure:<br /><br>• Death<br /><br>• Myocardial infarction<br /><br>• Persistent phrenic nerve palsy<br /><br>• Stroke<br /><br>• Transient ischemic attack (TIA)<br /><br>• Peripheral or organ thromboembolism<br /><br>• Cardiac tamponade / perforation<br /><br>• Pericarditis<br /><br>• Pulmonary edema<br /><br>• Vascular access complications<br /><br>• Heart block<br /><br>• Gastric motility/pyloric spasm disorders<br /><br><br /><br>Late onset (any time through the completion of 12 month follow-up visit)<br /><br>• Pulmonary vein stenosis<br /><br>• Atrio-esophageal fistula </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Severe Ablation Complications<br /><br>2. Nonserious / Serious CSEs<br /><br>3. Post-Blanking Direct Current Cardioversions<br /><br>4. Post-Blanking Arrhythmia Hospitalizations<br /><br>5. Any Related SAE<br /><br>6. Any Related Stroke or TIA </p><br>