Clinical trial NCT03882021: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Cardiac Arrhythmia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects enrolled will undergo the same mapping and ablation protocol.
Primary purpose: DIAGNOSTIC

Brief summary: The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

Detailed description: This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification.

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.

Eligibility criteria: Inclusion Criteria:

1. Documented atrial fibrillation with planned endocardial ablation procedure
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:

1. Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
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

Primary outcomes:
measure: Percentage of Subjects With One-year Success
timeFrame: the end of the 3-month blanking period to 12 months following a single ablation procedure
Secondary outcomes:
Other outcomes:
measure: Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy
timeFrame: the end of the 3-month blanking period to 12 months after initial ablation procedure
measure: Percentage of Subjects With Single Procedure Clinical Success
timeFrame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
measure: Percentage of Subjects With Freedom From AF/AFL/AT
timeFrame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
measure: Number of Subjects With Acute Procedural Success
timeFrame: During procedure, an average of 160 minutes
measure: Number of Subjects With Arrhythmia Recurrence
timeFrame: 12 months
measure: Left Atrium (LA) Information: LA Volume (LAV)
timeFrame: Baseline
measure: Left Atrium (LA) Information: LA Diameter (LAD)
timeFrame: Baseline
measure: Reportable Adverse Events
timeFrame: 12 months
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
state: Upr Aus
city: Brno
country: Czechia
facility: FN U sv. Anny v Brno
state: Moravia-Silesia
city: Saint-Denis Cedex
country: France
facility: CHR de La Reunion - Site du CHFG
state: ILE
city: Nantes
country: France
facility: Hôpital Privé du Confluent
state: Paysdel
city: Villeurbanne
country: France
facility: Médipôle Lyon-Villeurbanne
state: Rhone
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt GmbH
state: Bavaria
city: Bad Bevensen
country: Germany
facility: Herz- u. Gefäßzentrum Bad Bevensen
state: L Saxon
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombard
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Tuscany
city: Groningen
country: Netherlands
facility: Universitair Medische Centrum Groningen
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
state: Lisbon
city: Santiago De Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
state: Galicia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Abbott
name: Kristin Ruffner
role: STUDY_DIRECTOR
References: