- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03437733
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins. (SHINE)
1 grudnia 2020 zaktualizowane przez: Biosense Webster, Inc.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
98
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Prague, Czechy
- Na Homolce Hospital
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Bari, Włochy
- Ospedale "F. Miulli"
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Milan, Włochy
- Centro Cardiologico Monzino
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Liverpool, Zjednoczone Królestwo
- Liverpool Heart and Chest Hospital
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London, Zjednoczone Królestwo
- Bart's Health NHS Trust
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 75 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Diagnosed with Symptomatic Paroxysmal AF.
- Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
- Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
- Age 18-75 years.
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
- Signed Patient Informed Consent Form.
Exclusion Criteria:
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF.
- Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
- Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion.
- Any percutaneous coronary intervention (PCI) within the past 2 months.
- Valve repair or replacement and presence of a prosthetic valve.
- Any carotid stenting or endarterectomy.
- Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
- Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
- LA antero posterior diameter > 50 mm
- Any PV with a diameter ≥ 26 mm
- Left Ventricular Ejection Fraction (LVEF) < 40%.
- Contraindication to anticoagulation (e.g. heparin).
- History of blood clotting or bleeding abnormalities.
- Myocardial infarction within the past 2 months.
- Documented thromboembolic event [including transient ischemic attack(TIA)] within the past 12 months.
- Rheumatic Heart Disease.
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Unstable angina.
- Acute illness or active systemic infection or sepsis.
- Diagnosed atrial myxoma or interatrial baffle or patch.
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
- 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.
- Enrollment in an investigational study evaluating another device, biologic, or drug.
- Has known pulmonary vein stenosis.
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- Presence of an Inferior Vena Cava (IVC) filter
- Presence of a condition that precludes vascular access.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.
Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being
Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:
- Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Intervention
Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter
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RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis
Ramy czasowe: Up to 90 days (post initial mapping and ablation procedure)
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A Primary AEs is an event which occurred within 90 days following initial ablation procedure.
Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.
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Up to 90 days (post initial mapping and ablation procedure)
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Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding
Ramy czasowe: Up to 7 days (post initial mapping and ablation procedure)
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A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.
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Up to 7 days (post initial mapping and ablation procedure)
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Percentage of Participants With Acute Procedural Success
Ramy czasowe: Day 1
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Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).
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Day 1
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Participants With Individual PAE From Primary Composite
Ramy czasowe: Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)
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A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.
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Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)
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Number of Participants With Serious Adverse Device Effects (SADEs)
Ramy czasowe: Up to 405 Days
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An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device.
SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.
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Up to 405 Days
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Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure
Ramy czasowe: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
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Serious non-primary adverse event was defined as SAE that are not primary adverse events.
Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.
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Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
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Number of Participants With Non-serious Adverse Events
Ramy czasowe: Up to 405 Days
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An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.
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Up to 405 Days
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Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli
Ramy czasowe: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)
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Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.
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Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)
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Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli
Ramy czasowe: Up to 405 Days
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Number of participants with symptomatic and asymptomatic cerebral emboli was reported
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Up to 405 Days
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Number of Participants With New or Worsening Neurologic Deficits
Ramy czasowe: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month
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Number of participants with new or worsening neurologic deficits was reported.
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Pre-procedure, discharge, 1 Month, 3 Month and 6 Month
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Number of Participants With NIHSS Scores
Ramy czasowe: Pre-procedure and at discharge (Up to 405 Days)
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The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke.
The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
The individual scores from each item are summed to calculate a patient's total NIHSS score.
The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum).
Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).
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Pre-procedure and at discharge (Up to 405 Days)
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Number of Participants With MoCA Scores
Ramy czasowe: Up to 405 Days
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Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30.
A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.
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Up to 405 Days
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Number of Participants With Hospitalization for Cardiovascular Events
Ramy czasowe: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
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Hospitalization was defined as prolonged stay greater than or equal to (>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure >= 1 calendar day.
Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not.
Hence this data was not contributed in serious Adverse events until met the AE definition.
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Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
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Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants
Ramy czasowe: Up to 405 Days
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Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported.
Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.
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Up to 405 Days
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Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers
Ramy czasowe: Up to 405 Days
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Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.
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Up to 405 Days
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Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL
Ramy czasowe: Up to 6 Months
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Percentage of participants with six-month arrythmia recurrence [defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes >30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)] was reported.
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Up to 6 Months
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Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL
Ramy czasowe: Up to 12 Months
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Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode >30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.
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Up to 12 Months
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Współpracownicy i badacze
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Sponsor
Publikacje i pomocne linki
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
28 lutego 2018
Zakończenie podstawowe (Rzeczywisty)
1 lutego 2019
Ukończenie studiów (Rzeczywisty)
17 października 2019
Daty rejestracji na studia
Pierwszy przesłany
13 lutego 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 lutego 2018
Pierwszy wysłany (Rzeczywisty)
19 lutego 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 grudnia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 grudnia 2020
Ostatnia weryfikacja
1 listopada 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BWI_2017_01
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
produkt wyprodukowany i wyeksportowany z USA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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