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 (WAVE-MAP AF)

June 22, 2022 updated by: Abbott Medical Devices
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upr Aus
      • Linz, Upr Aus, Austria, 4021
        • Kepler Universitätsklinikum GmbH
  • Czechia
    • Moravia-Silesia
      • Brno, Moravia-Silesia, Czechia, 656 91
        • FN U sv. Anny v Brno
  • France
    • ILE
      • Saint-Denis Cedex, ILE, France, 97405
        • CHR de La Reunion - Site du CHFG
    • Paysdel
      • Nantes, Paysdel, France, 44200
        • Hopital prive du Confluent
    • Rhone
      • Villeurbanne, Rhone, France, 69626
        • Medipole Lyon-Villeurbanne
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW
    • Bavaria
      • Ingolstadt, Bavaria, Germany, 85049
        • Klinikum Ingolstadt GmbH
    • L Saxon
      • Bad Bevensen, L Saxon, Germany, 29549
        • Herz- u. Gefäßzentrum Bad Bevensen
  • Italy
    • Lombard
      • Milano, Lombard, Italy, 20132
        • Ospedale San Raffaele
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medische Centrum Groningen
  • Portugal
    • Lisbon
      • Carnaxide, Lisbon, Portugal, 2799-523
        • Hospital de Santa Cruz
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
    • Galicia
      • Santiago De Compostela, Galicia, Spain, 15706
        • Complexo Hospitalario Universitario De Santiago
  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mapping protocol with GRID catheter
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year success
Time Frame: 12 months
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. Survival analysis will be conducted to analyze time-to-event variables.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute procedural success
Time Frame: During procedure
Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates, and with exact 95% Clopper-Pearson confidence intervals.
During procedure
Success post blanking period through 12 months using different definitions
Time Frame: 12 months
  1. Freedom from symptomatic AF/AFL/AT after removal from antiarrhythmic drug therapy
  2. Single procedure clinical success defined as freedom from symptomatic atrial fibrillation, atrial flutter and atrial tachycardia without a new or increased dose of class I or III antiarrhythmic drug
  3. Freedom from atrial fibrillation, atrial flutter and atrial tachycardia Survival analysis will be conducted to analyze time-to-event variables.
12 months
Arrhythmia recurrence
Time Frame: 12 months
Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies. The data will be summarized with subject counts and percentages/rates, and with exact 95% Clopper-Pearson confidence intervals.
12 months
Left atrium (LA) information
Time Frame: During procedure
LA volume will be summarized with the numbers of observations, means with standard deviations, quartiles, minimums, maximums and 95%confidence intervals for the means.
During procedure
Left atrium information
Time Frame: During procedure
LA diameter will be summarized with the numbers of observations, means with standard deviations, quartiles, minimums, maximums and 95%confidence intervals for the means.
During procedure
Reportable Adverse Events
Time Frame: 12 months
including any device-, procedure-, or death-related events. The data will be summarized with subject counts and percentages/rates, and with exact 95% Clopper-Pearson confidence intervals.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Kristin Ruffner, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

January 13, 2022

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 16, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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