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

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Cardiac Arrhythmia
• Interventions: Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter.

• Registration Number: NCT03882021
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The aim is to use the GRID 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.

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-16
• Study First Posted: 2019-03-20
• Study Start: 2019-08-26
• Primary Completion: 2021-11-30
• Study Completion: 2022-01-13
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mapping protocol with Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter	A specific electrophysiology mapping protocol is applicable with the GRID catheter.	All patient will undergo a protocol required mapping protocol using the GRID catheter.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With One-year Success	the end of the 3-month blanking period to 12 months following a single ablation procedure	Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.

Trial Locations

Locations (15)

Kepler Universitätsklinikum GmbH; 🇦🇹 Linz, Upr Aus, Austria

Hospital de Santa Cruz; 🇵🇹 Carnaxide, Lisbon, Portugal

FN U sv. Anny v Brno; 🇨🇿 Brno, Moravia-Silesia, Czechia

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Herz- u. Gefäßzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, L Saxon, Germany

Hôpital Privé du Confluent; 🇫🇷 Nantes, Paysdel, France

CHR de La Reunion - Site du CHFG; 🇫🇷 Saint-Denis Cedex, ILE, France

Médipôle Lyon-Villeurbanne; 🇫🇷 Villeurbanne, Rhone, France

Klinikum Ingolstadt GmbH; 🇩🇪 Ingolstadt, Bavaria, Germany

Universitair Medische Centrum Groningen; 🇳🇱 Groningen, Netherlands

Ospedale San Raffaele; 🇮🇹 Milano, Lombard, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Tuscany, Italy

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Complexo Hospitalario Universitario de Santiago; 🇪🇸 Santiago De Compostela, Galicia, Spain

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom