En studie som vurderer langsiktig sikkerhet og effektivitet i behandlingshåndteringen av atrieflimmer med VARIPULSE-katetersystemet (AdmIREPAS)
Vurdering av langsiktig sikkerhet og effektivitet i behandlingshåndtering av atrieflimmer med VARIPULSE™ katetersystemet
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Emily Purcell
- Telefonnummer: +1 949 230 3701
- E-post: EPurcel1@its.jnj.com
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85018
- Rekruttering
- Phoenix Cardiovascular Research Group
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Tucson, Arizona, Forente stater, 85704
- Rekruttering
- Tucson Medical Center Pima Heart and Vascular
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California
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Fountain Valley, California, Forente stater, 92708
- Rekruttering
- OC Memorial
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Ventura, California, Forente stater, 93003
- Rekruttering
- Community Memorial Hospital
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Rekruttering
- Aurora Denver Cardiology Associates
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- Mayo Clinic in Florida
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Miami, Florida, Forente stater, 33133
- Rekruttering
- HCA Florida Mercy Hospital
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Orlando, Florida, Forente stater, 32806
- Rekruttering
- Orlando Health Heart and Vascular Institute
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Illinois
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Naperville, Illinois, Forente stater, 60540
- Rekruttering
- Edward Hospital Midwest Cardiovascular Institute
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa Hospitals and Clinics
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- Rekruttering
- University of Kansas Medical Center
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Overland Park, Kansas, Forente stater, 66211
- Rekruttering
- The Kansas City Heart Rhythm Institute
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Rekruttering
- Henry Ford Health System
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Ypsilanti, Michigan, Forente stater, 48197
- Rekruttering
- Trinity Health
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- Mayo Clinic Rochester
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New Jersey
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Trenton, New Jersey, Forente stater, 08638
- Rekruttering
- Capital Health Regional Medical Center
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New York
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Lake Success, New York, Forente stater, 11042
- Rekruttering
- Northwell Health Physician Partners Cardiology
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The Bronx, New York, Forente stater, 10467
- Rekruttering
- Albert Einstein College Of Medicine - Montefiore Medical Center
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Ohio
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Cincinnati, Ohio, Forente stater, 45229
- Rekruttering
- The Christ Hospital
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Springfield, Ohio, Forente stater, 45504
- Rekruttering
- Springfield Medical Center
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Texas
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Austin, Texas, Forente stater, 78705
- Rekruttering
- Texas Cardiac Arrhythmia Research Foundation
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Fort Worth, Texas, Forente stater, 76104
- Rekruttering
- Baylor Scott and White Research Institute
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Plano, Texas, Forente stater, 75093
- Rekruttering
- Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
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Virginia
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Winchester, Virginia, Forente stater, 22601
- Rekruttering
- Winchester 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:
- Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
- Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
- Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
- Previous surgical or catheter ablation for AF
- Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
- Current enrollment in an investigational study evaluating another device or drug
- Life expectancy less than 12 months
- Any contraindications as defined in the Protocol
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator. |
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
Tidsramme: Within 7 days post index procedure
|
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis. |
Within 7 days post index procedure
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Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes
Tidsramme: Day 61-1095 post-index procedure
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Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study. |
Day 61-1095 post-index procedure
|
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
- BWI202405
- BWI202405 (Annen identifikator: Biosense Webster, Inc.)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine 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
Legemiddel- og utstyrsinformasjon, studiedokumenter
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