Идёт набор NCT07527299

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

Без фазы С лечением Atrial Fibrillation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: VARIPULSE Catheter System, LAAO Device.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial

Обзор

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \[PVI\] and superior vena cava isolation \[SVCI\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.

Вмешательства

Устройство VARIPULSE Catheter System
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.
Устройство LAAO Device
LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).

Первичные конечные точки

Number of Participants with Early Onset Primary Adverse Events (PAEs) [Срок оценки: Up to approximately 7 days post-procedure]
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes [Срок оценки: Day 61 up to Day 180]

Вторичные конечные точки (2)

Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes [Срок оценки: Day 61 up to Day 365]
Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score [Срок оценки: Baseline, at 12 months post-procedure]

Критерии участия

Критерии включения

Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days in duration and less than 365 days in duration, documented by: i. A physician's note documenting diagnosis of symptomatic PsAF, as defined above; and ii. Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than (>) 365 days prior to enrollment); or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
Participant is aged 18 - 80 years at the time of informed consent
Participant is willing and capable of providing informed consent
Participant is able and willing to comply with all pre-, post- and follow-up testing and requirement

Left atrial appendage occlusion (LAAO) concomitant subset:

\- Participant is clinically indicated for a LAAO procedure

Критерии исключения

Participant has continuous AF > 365 days (longstanding persistent AF)
Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
Participant has had previous surgical or catheter ablation for AF
Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
Participant has LA (left atrial) anteroposterior >= 55 millimeter (mm) (by magnetic resonance imaging \[MRI\], computed tomography \[CT\], or transthoracic echocardiogram \[TTE\]), or if LA diameter is not available, non-index volume >100 milliliter (mL) confirmed within 365 days prior to enrollment
Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
Participant has severely compromised left ventricular ejection fraction (left ventricle ejection fraction \[LVEF\] less than \[<\] 40 percent \[%\]) confirmed by imaging performed within 180 days prior to enrollment
Participant has uncontrolled heart failure or New York heart association (NYHA) Class III or IV functional classification
Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
Participant has had a thromboembolic event (including transient ischemic attack \[TIA\]) within the past 180 days prior to enrollment
Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within past 60 days prior to enrollment
Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
Participant has had valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
Participant has unstable angina within past 6 months prior to enrollment
Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
Participant has a significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
Participant has a pre-existing hemi-diaphragmatic paralysis
Participant has an acute illness, active systemic infection, or sepsis
Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to \[>=\] 60 milliliters \[mL\]/beat, Regurgitant fraction >= 50%, and/or Effective regurgitant orifice area >= 0.40 square centimeter \[cm\^2\])
Participants with an implanted metal cardiac device that may interfere with the pulsed field energy field are excluded, including but not limited to: -MitraClip, -LAAO devices (for example, WATCHMAN, Amulet), -Double-coiled implantable cardioverter-defibrillators (ICDs). This exclusion does not apply to participants with any of the following devices: -Coronary stents, -Implanted pacemakers, -Single-coiled ICDs, -Implantable loop recorders (ILRs)
Participant has a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter) - Participant is currently enrolled in an investigational study evaluating another device or drug
Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
Participant has a life expectancy of less than 365 days
Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs)
Participant has contraindications for the ablation of the SVC

LAAO concomitant subset:

Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device
Participant with prior LAAO procedure (attempted or successful)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет