Ripetizione dell'ablazione della fibrillazione atriale persistente, inclusa l'ablazione transcatetere dell'istmo mitralico, con il sistema di ablazione a campo pulsato FARAPULSE (ReMATCH)
Lo studio ReMATCH è uno studio prospettico, a braccio singolo, in aperto, multicentrico che utilizza il sistema FARAPULSE PFA, compresi i cateteri FARAWAVE e FARAPOINT PFA
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
The goal of this study is to evaluate the safety and effectiveness of using the FARAWAVE™ and FARAPOINT™ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Melbourne, Australia
- The Alfred Hospital
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New South Wales
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New Lambton Heights, New South Wales, Australia, 606-8507
- John Hunter Hospital
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Queensland
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Brisbane, Queensland, Australia, 4001
- St. Andrew's War Memorial Hospital
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Victoria
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Clayton, Victoria, Australia, 3168
- Victorian Heart Hospital
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Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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Alabama
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Mobile, Alabama, Stati Uniti, 36607
- Mobile Infirmary Medical Center
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Arkansas
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Jonesboro, Arkansas, Stati Uniti, 72401
- Arrhythmia Research Group-Research Facility
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California
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Los Angeles, California, Stati Uniti, 90033
- University of Southern California Hospital
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Oxnard, California, Stati Uniti, 93030
- St. John's Regional Medical Center
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Stanford, California, Stati Uniti, 94305
- Stanford University Medical Center
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Colorado
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Littleton, Colorado, Stati Uniti, 80120
- South Denver Cardiology Associates, PC
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Florida
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Miami, Florida, Stati Uniti, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, Stati Uniti, 34102
- Naples Comprehensive Health
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Orlando, Florida, Stati Uniti, 32803
- AdventHealth Orlando-Hospital
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Tampa, Florida, Stati Uniti, 33606
- Tampa General Hospital
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Tampa, Florida, Stati Uniti, 33613
- AdventHealth Tampa-Hospital
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University Hospital
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Macon, Georgia, Stati Uniti, 32201
- Atrium Health Navicent The Medical Center
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Savannah, Georgia, Stati Uniti, 31404
- Memorial Health University Medical Center
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Idaho
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Boise, Idaho, Stati Uniti, 83712
- St. Luke's Boise Medical Center
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Illinois
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Oak Lawn, Illinois, Stati Uniti, 60453
- Advocate Christ Medical Center-Hospital
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Fall River, Massachusetts, Stati Uniti, 02720
- Southcoast Physicians Group
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Michigan
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Royal Oak, Michigan, Stati Uniti, 48073
- William Beaumont Hospital-Hospital
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Marlton, New Jersey, Stati Uniti, 08053
- Virtua Health Inc.
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- Lovelace Medical Center
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New York
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Manhasset, New York, Stati Uniti, 11030
- Northwell Health
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New York, New York, Stati Uniti, 10065
- Weill Cornell Medical University
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45242
- Bethesda North Hospital
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Columbus, Ohio, Stati Uniti, 43210
- Ohio State University Medical Center
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Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74104
- Oklahoma Heart Institute
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29406
- Trident Medical Center
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Texas
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Austin, Texas, Stati Uniti, 78705
- Texas Cardiac Arrhythmia Research
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Tyler, Texas, Stati Uniti, 75701
- Christus Trinity Mother Frances Health System
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Utah
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Salt Lake City, Utah, Stati Uniti, 84124
- St. Mark's Hospital
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Sentara Norfolk General Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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Taipei, Taiwan
- Taipei Veterans General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- ≥ 18 years of age, or older if required by local law
- Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
- Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
- Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.
OR
- If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
- Willing and capable of providing informed consent
- Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
Exclusion Criteria:
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Atrial exclusions - Any of the following atrial conditions:
a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus
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Cardiovascular exclusions - Any of the following CV conditions:
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History of sustained ventricular tachycardia or any ventricular fibrillation
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AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
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Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.
Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment
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Presence of any of the following:
• Any prosthetic heart valve, ring or repair
• Moderate to severe mitral valve stenosis
• More than moderate mitral regurgitation (>3+)
- Moderate to severe aortic stenosis
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Hypertrophic cardiomyopathy
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Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
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Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
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Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
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Any of the following conditions at baseline:
- Heart failure associated with NYHA Class III or IV
- Documented LVEF < 40% as documented within the previous 12 months
- Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
- Body Mass Index (BMI) >45.0
- CHA2DS2-VASc score ≥5
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Any of the following events within 90 Days of the Consent Date:
- Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease
- Cardiac surgery: Any cardiac surgery
- Heart failure hospitalization: Heart failure hospitalization
- Pericardium: Pericarditis or symptomatic pericardial effusion
- GI bleeding: Gastrointestinal bleeding
- Neurovascular event: Stroke, TIA, or intracranial bleeding
- Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
- Carotid intervention: Carotid stenting or endarterectomy
- Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%
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Any of the following congenital conditions:
- Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- Methemoglobinemia: History of known congenital methemoglobinemia
- G6PD deficiency: History of known G6PD deficiency
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Any of the following conditions:
- Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
- Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
l. Pregnancy: Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period m. General health conditions: Health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
n. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility.
p. Life expectancy: Predicted life expectancy less than one (1) year
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Altro: Single Arm Prospective
Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System. |
The FARAPULSE™ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation. The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy. The FARAPOINT™ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Primary safety endpoint rate
Lasso di tempo: 60 days
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The primary safety endpoint (PSE) is the proportion of Treatment subjects with one or more device or procedure-related Composite Serious Adverse Events (CSAEs) following the Repeat Ablation Procedure. |
60 days
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The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success.
Lasso di tempo: 24 hours
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The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success). |
24 hours
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Moussa Mansour,, MD, Massachusetts General Hospital
Studiare le date dei record
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Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- PF313
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