[Teste de dispositivo que não foi aprovado ou liberado pela FDA dos EUA] (OMNY-AF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Adelaide, Austrália, 5000
- Royal Adelaide Hospital
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Parkville, Austrália, 03052
- Royal Melbourne Hospital
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Arizona
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Phoenix, Arizona, Estados Unidos, 85018
- Phoenix Cardiovascular Research Group
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California
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Burlingame, California, Estados Unidos, 94010
- Mills Peninsula Health Services
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Larkspur, California, Estados Unidos, 94939
- Cardiovascular Associates of Marin
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Newport Beach, California, Estados Unidos, 92663
- Hoag Memorial Hospital
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San Diego, California, Estados Unidos, 92123
- San Diego Cardiac Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, Estados Unidos, 32204
- Ascension St. Vincent's
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Jacksonville, Florida, Estados Unidos, 32207
- Baptist Health Research Institute
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Miami, Florida, Estados Unidos, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, Estados Unidos, 34102
- NCH Healthcare
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Orlando, Florida, Estados Unidos, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Estados Unidos, 30309
- Piedmont Healthcare
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Atlanta, Georgia, Estados Unidos, 30342
- Northside Hospital
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Savannah, Georgia, Estados Unidos, 31404
- Memorial Health University Medical Center
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Illinois
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Glenview, Illinois, Estados Unidos, 60026
- NorthShore University Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham And Women's Hospital
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Michigan
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Royal Oak, Michigan, Estados Unidos, 48073
- Beaumont Health Systems
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55414
- Minneapolis Heart Institute
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07960
- Morristown Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- New Mexico Heart Institute
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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New York, New York, Estados Unidos, 10075
- Lenox Hill Hospital
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New York, New York, Estados Unidos, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Roslyn, New York, Estados Unidos, 11576
- St Francis Hospital
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The Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27610
- WakeMed Heart & Vascular
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania Health System
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York, Pennsylvania, Estados Unidos, 17403
- York Hospital
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Texas
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Austin, Texas, Estados Unidos, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Houston, Texas, Estados Unidos, 77030
- Texas Heart Institute
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Utah
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Murray, Utah, Estados Unidos, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
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Norfolk, Virginia, Estados Unidos, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Diagnosed with symptomatic paroxysmal AF with:
- At least two symptomatic AF episodes within last six months from enrollment
- At least one electrocardiographically documented AF episode within twelve months prior to enrollment
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Failed at least one Class I or Class III antiarrhythmic drug
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Willing and capable to provide consent
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Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion Criteria:
- Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF
- Patients known to require ablation outside the PV ostia and outside the CTI region.
- Documented severe dilatation of the left atrium (LAD>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
- Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
- Documented severely compromised left ventricular ejection fraction (LVEF <40%) by imaging within 6 months prior to enrollment
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
- Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction [MI] within the past 2 months
- Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
- Valvular cardiac surgical/percutaneous procedure
- Unstable angina within 6 months
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Prior diagnosis of pulmonary vein stenosis
- Pre-existing hemi diaphragmatic paralysis
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Severe mitral regurgitation
- Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
- Presence of a condition that precludes vascular access
- Current enrollment in an investigational study evaluating another device or drug
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- Life expectancy less than 12 months
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Pulsed Field (PF) Ablation System
Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure. |
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
Prazo: 7 days post-procedure
|
Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), 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. |
7 days post-procedure
|
|
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes
Prazo: Day 91 to Day 365 post-procedure
|
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of >= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported. |
Day 91 to Day 365 post-procedure
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Prazo: Baseline, Month 12
|
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, Month 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BWI202303
- BWI202303 (Outro identificador: Biosense Webster, Inc.)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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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