High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
NCT ID: NCT03882021
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2019-08-26
2022-01-13
Brief Summary
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Detailed Description
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This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.
Approximately 300 subjects at up to 20 sites worldwide will be enrolled.
Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Mapping protocol with Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter
All patient will undergo a protocol required mapping protocol using the GRID catheter.
A specific electrophysiology mapping protocol is applicable with the GRID catheter.
The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.
Interventions
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A specific electrophysiology mapping protocol is applicable with the GRID catheter.
The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.
Eligibility Criteria
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Inclusion Criteria
2. Age 18 years or older
3. Able and willing to provide written informed consent prior to any clinical investigation related procedure
4. Able and willing to complete all required study procedures through 12 months
Exclusion Criteria
2. Previous ablation or surgery in the left atria
3. Implanted left atrial appendage occluder
4. Implanted mitral or tricuspid valve replacement
5. Implanted cardiac defibrillator (ICD)
6. Participation in another clinical investigation that may confound the results of this study
7. Pregnant or nursing
8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
9. Life expectancy less than 12 months
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Kristin Ruffner
Role: STUDY_DIRECTOR
Abbott
Locations
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Kepler Universitätsklinikum GmbH
Linz, UPR AUS, Austria
FN U sv. Anny v Brno
Brno, Moravia-Silesia, Czechia
CHR de La Reunion - Site du CHFG
Saint-Denis, ILE, France
Hôpital Privé du Confluent
Nantes, Paysdel, France
Médipôle Lyon-Villeurbanne
Villeurbanne, Rhone, France
Klinikum Ingolstadt GmbH
Ingolstadt, Bavaria, Germany
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, L Saxon, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Ospedale San Raffaele
Milan, Lombard, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Universitair Medische Centrum Groningen
Groningen, , Netherlands
Hospital de Santa Cruz
Carnaxide, Lisbon District, Portugal
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10275
Identifier Type: -
Identifier Source: org_study_id
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