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

NCT03882021 | Completed Results

• 1 other identifier: ABT-CIP-10275
• Study Type: interventional
• Target: 300
• Locations: 9 countries
• Sites: 15

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.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With One-year Success

  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.

  the end of the 3-month blanking period to 12 months following a single ablation procedure

Other Outcomes (8)

• Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy

  the end of the 3-month blanking period to 12 months after initial ablation procedure

• Percentage of Subjects With Single Procedure Clinical Success

  the end of the 3-month blanking period to 12 months following the initial ablation procedure

• Percentage of Subjects With Freedom From AF/AFL/AT

  the end of the 3-month blanking period to 12 months following the initial ablation procedure

Study Arms (1)

Mapping protocol with Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter

OTHER

All patient will undergo a protocol required mapping protocol using the GRID catheter.

Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter.

Interventions

A specific electrophysiology mapping protocol is applicable with the GRID catheter. PROCEDURE

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.

Mapping protocol with Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented atrial fibrillation with planned endocardial ablation procedure
• Age 18 years or older
• Able and willing to provide written informed consent prior to any clinical investigation related procedure
• Able and willing to complete all required study procedures through 12 months

You may not qualify if:

• Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
• Previous ablation or surgery in the left atria
• Implanted left atrial appendage occluder
• Implanted mitral or tricuspid valve replacement
• Implanted cardiac defibrillator (ICD)
• Participation in another clinical investigation that may confound the results of this study
• Pregnant or nursing
• 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.
• Life expectancy less than 12 months

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (15)

Kepler Universitätsklinikum GmbH

Linz, UPR AUS, 4021, Austria

Location

FN U sv. Anny v Brno

Brno, Moravia-Silesia, 656 91, Czechia

Location

CHR de La Reunion - Site du CHFG

Saint-Denis, ILE, 97405, France

Location

Hôpital Privé du Confluent

Nantes, Paysdel, 44200, France

Location

Médipôle Lyon-Villeurbanne

Villeurbanne, Rhone, 69626, France

Location

Klinikum Ingolstadt GmbH

Ingolstadt, Bavaria, 85049, Germany

Location

Herz- u. Gefäßzentrum Bad Bevensen

Bad Bevensen, L Saxon, 29549, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Ospedale San Raffaele

Milan, Lombard, 20132, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

Universitair Medische Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Hospital de Santa Cruz

Carnaxide, Lisbon District, 2799-523, Portugal

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Zitella Verbick
• Organization: Abbott

laura.zitellaverbick@abbott.com

+1-612-961-7336

Study Officials

• Kristin Ruffner

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects enrolled will undergo the same mapping and ablation protocol.

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 20, 2019
• Study Start: August 26, 2019
• Primary Completion: November 30, 2021
• Study Completion: January 13, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Locations

IT (2); ES (2); GB (1); AU (1); FR (3); DE (3); NL (1); CZ (1); PT (1)