Atrial Fibrillation
Conditions
Brief summary
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).
Interventions
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software will be used.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF) * Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation * Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD * Age 18-75 years * Willing and capable of providing consent * Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion criteria
* Continuous AF greater than (\>) 12 months (1-Year) (Longstanding Persistent AF) * Previous surgical or catheter ablation for atrial fibrillation * Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \[PCI\]) * Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure * Any carotid stenting or endarterectomy * Presence of left atrium (LA) thrombus * Severe dilatation of the LA (left atrial diameter \[LAD\] \>50 millimeters \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\]) * Severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\]) * Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study * Prior diagnosis of pulmonary vein stenosis * Pre-existing hemi diaphragmatic paralysis * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) * Myocardial infarction (MI) within the past 2 months (60 days prior to consent date) * Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 6 months \[180 days prior to consent date\]) * Rheumatic Heart Disease * Uncontrolled heart failure or New York heart association (NYHA) function class III or IV * Severe mitral regurgitation * Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months * Unstable angina pectoris within the past 6 months prior to consent date * Acute illness or active systemic infection or sepsis * Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \[Body Mass Index \>40 kilogram per meter square {kg/m\^2}\], renal insufficiency (with an estimated creatinine clearance \< 30 milliliters per minute {mL/min}/1.73 m\^2) * Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation * Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter * Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava \[IVC\] filter) * Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \[COPD\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms * Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Current enrollment in an investigational study evaluating another device, biologic, or drug * Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU) * Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being * Life expectancy less than 12 months * Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter/defibrillators (ICDs),etc. (at principal investigator \[PI\] discretion) * Presence of iron-containing metal fragments in the body * Unresolved pre-existing neurological deficit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Effectiveness | Intraoperative | Acute effectiveness, that is, acute procedural success, which is defined as electrical isolation of clinically relevant targeted PVs (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure will be reported. |
| Pulmonary Vein Isolation (PVI) Durability | At 3 months post index ablation procedure | PVI durability is defined as sustained isolation of pulmonary vein (PVs) that are targeted in the index ablation procedure, which is evidenced by the confirmation of isolation via the electro-anatomical mapping 90 (+/- 14 days) days post index ablation procedure. |
| Pulsed Field (PF) Application Time | Intraoperative | PF application time will be reported. |
| Number of PF applications by PV | Intraoperative | Number of PF applications by PV will be reported. |
| Tissue Proximity Indication (TPI) | Intraoperative | TPI will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Serious Adverse Device Effects (SADE) (Within Seven (7) days) of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan | Up to 7 days post index ablation procedure | A SADE is an adverse device effect that has resulted in any of the consequences characteristic of an serious adverse event (SAE). A SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect. |
| Occurrence of Unanticipated Serious Adverse Device Effects (USADEs) | Up to 3 months post index ablation procedure | An USADE is any SAE on health, safety, any life-threatening problem, or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, outcome, or degree of incidence in the current investigational plan or risk analysis report, or any other unanticipated serious problem associated with a device that relates to rights, safety, or welfare of participants. |
| Occurrence of SAEs | At 7 days, 8 to 30 days (peri-procedural) and up to 3 months post index ablation procedure | An SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect. |
| Occurrence of Non-Serious Adverse Events (Non-SAEs) | Up to 3 months post index ablation procedure | An Adverse Event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device. |
| Occurrence of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations | Up to 3 months post index ablation procedure | Occurrence of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation. |
| Anatomical Location of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations | Up to 3 months post index ablation procedure | Anatomical location of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation. |
| Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations | Up to 3 months post index ablation procedure | Size of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation. |
| Occurrence of New or Worsening Neurological Deficits | Up to 3 months post index ablation procedure | Occurrence of new or worsening neurological deficits post-ablation and at follow-up, compared to baseline will be assessed. |
| Mini Mental State Examination (MMSE) | Baseline up to 3 months post index ablation procedure | The MMSE is a, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment. |
| National Institutes of Health Stroke Scale (NIHSS) | Baseline up to 3 months post index ablation procedure | The NIHSS is a clinician-reported measure of neurological deficit with scores ranging from 0 to 42. No stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42). |
| Modified Rankin Scale (mRS) | Baseline up to 3 months post index ablation procedure | The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) : * mRS 0: No symptoms. * mRS 1: No significant disability. Able to perform all usual activities, despite some symptoms. * mRS 2: Slight disability. Independent but unable to perform usual activities (work, sports, leisure). * mRS 3. Moderate disability. Requires assistance, but able to walk alone. * mRS 4: Moderately severe disability. Walking assistance and/or daily living activities not possible. * mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention. * mRS 6: Death. |
| Occurrence of Severe Pulmonary Vein (PV) Stenosis | Up to 3 months post index ablation procedure | Occurrence of severe PV stenosis up to 3 months post-ablation as determined by Computed Tomography (CT)/ Magnetic Resonance Angiogram (MRA) evaluations. |
Countries
Belgium, Denmark, France, Germany, Italy, Lithuania, Netherlands
Contacts
CONTACTNathalie Macours
STUDY_DIRECTORBiosense Webster, Inc. Clinical Trial
Biosense Webster, Inc.
Outcome results
None listed