En studie av VARIPULSE-kateter hos deltakere med vedvarende atrieflimmer som gjennomgår isolasjon av lungevenene og øvre hulvene (SPAA PFA)
Vurdering av sikkerheten og effektiviteten til VARIPULSE™-katetersystemet i behandlingen av deltakere med persisterende atrieflimmer som gjennomgår lungevenøs isolasjon (med eller uten isolasjon av bakvegg) og isolasjon av øvre hulvene: En randomisert kontrollert studie
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Narvelle Delabruere
- Telefonnummer: 949-933-1710
- E-post: NDelabru@its.jnj.com
Studer Kontakt Backup
- Navn: Josiah M Gillespie
- Telefonnummer: 405-924-0777
- E-post: jgille12@its.jnj.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35243
- Rekruttering
- Grandview Medical Center
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Arizona
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Tucson, Arizona, Forente stater, 85741
- Rekruttering
- Pima Heart and Vascular
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Arkansas
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Jonesboro, Arkansas, Forente stater, 72401
- Rekruttering
- Arrhythmia Research Group
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California
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Santa Monica, California, Forente stater, 90404
- Rekruttering
- Pacific Heart Institute Cedars Sinai Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Rekruttering
- Aurora Denver Cardiology Associates
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Connecticut
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Hartford, Connecticut, Forente stater, 06102
- Rekruttering
- Hartford Hospital
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Florida
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Atlantis, Florida, Forente stater, 33462
- Rekruttering
- JFK Medical Center
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Kentucky
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Edgewood, Kentucky, Forente stater, 41017
- Rekruttering
- Saint Elizabeth Medical Center
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Michigan
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Traverse City, Michigan, Forente stater, 49684
- Rekruttering
- Munson Medical Center
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New York
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The Bronx, New York, Forente stater, 10467
- Rekruttering
- Albert Einstein College Of Medicine - Montefiore Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73120
- Rekruttering
- Oklahoma Heart Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- Penn Presbyterian Medical Center
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Wisconsin
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Janesville, Wisconsin, Forente stater, 53548
- Rekruttering
- Mercy Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
- 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
Exclusion criteria:
- 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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: VARIPULSE Catheter System: PVI and SVCI
Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation for the first-time with the VARIPULSE Catheter System will undergo the ablation procedure for PVI and SVCI. Additionally, a subset of participants will undergo a concomitant left atrial appendage occlusion (LAAO) procedure. All participants will be followed for up to 36 months post procedure. |
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used. LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU). |
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Eksperimentell: VARIPULSE Catheter System: PVI and SVCI + PWI
Participants with PsAF undergoing catheter ablation for the first-time with VARIPULSE catheter system will undergo the ablation procedure for PVI and SVCI along with posterior wall isolation (PWI). Additionally, a subset of participants will undergo a concomitant LAAO procedure. All participants will be followed for up to 36 months post procedure. |
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used. LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Early Onset Primary Adverse Events (PAEs)
Tidsramme: Up to approximately 7 days post-procedure
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PAEs include early onset AEs such as esophageal perforating complications, phrenic nerve paralysis (PNP; permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), death (device or procedure related), stroke/ cerebrovascular accident (CVA), major vascular access, complication/bleeding, thromboembolism, myocardial Infarction (MI), transient ischemic attack (TIA), pericarditis, pulmonary edema (respiratory insufficiency), heart block, and vagal nerve injury/ gastroparesis. |
Up to approximately 7 days post-procedure
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Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Tidsramme: Day 61 up to Day 180
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Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter [AF, AT or AFL] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current (DC) cardioversion procedure. |
Day 61 up to Day 180
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Tidsramme: Day 61 up to Day 365
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Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, AF, AT or AFL of unknown origin) episodes based on electrocardiographic and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, NSC failure, AAD failure and any DC cardioversion (DCCV) procedure. |
Day 61 up to Day 365
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Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score
Tidsramme: Baseline, at 12 months post-procedure
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The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms. |
Baseline, at 12 months post-procedure
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BWI202517
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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