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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)

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ClinicalTrials.gov Identifier: NCT03882021
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Cardiac Arrhythmia Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects enrolled will undergo the same mapping and ablation protocol.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882021


Contacts
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Contact: Krista Hicks +1-859-816-1567 krista.hicks@abbott.com
Contact: Karolien Timmermans +32497513921 karolien.timmermans@abbott.com

Locations
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Austria
Kepler Universitätsklinikum GmbH Recruiting
Linz, Upr Aus, Austria, 4021
Contact: Clemens Steinwender, MD, Prim.         
Czechia
FN U sv. Anny v Brno Recruiting
Brno, Moravia-Silesia, Czechia, 656 91
Contact: Zdenek Starek, MD, Ph.D         
France
CHR de La Reunion - Site du CHFG Recruiting
Saint-Denis Cedex, ILE, France, 97405
Contact: Gael CLERICI, MD         
Hôpital Privé du Confluent Recruiting
Nantes, Paysdel, France, 44200
Contact: Daniel Gras, MD         
Médipôle Lyon-Villeurbanne Recruiting
Villeurbanne, Rhone, France, 69626
Contact: Herve Poty, MD         
Germany
Klinikum Ingolstadt GmbH Recruiting
Ingolstadt, Bavaria, Germany, 85049
Contact: Karlheinz Seidl, Prof. Dr. med.         
Herz- u. Gefäßzentrum Bad Bevensen Recruiting
Bad Bevensen, L Saxon, Germany, 29549
Contact: Evgeny Lyan, MD         
Herz- und Diabeteszentrum NRW Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Philipp Sommer, PhD         
Italy
Ospedale San Raffaele Recruiting
Milano, Lombard, Italy, 20132
Contact: Paolo Della Bella, Prof. MD         
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Tuscany, Italy, 56126
Contact: Maria Grazia Bongiorni, MD         
Netherlands
Universitair Medische Centrum Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Yuri Blaauw, MD         
Portugal
Hospital de Santa Cruz Recruiting
Carnaxide, Lisbon, Portugal, 2799-523
Contact: Pedro Adragao, Prof. Dr.         
Spain
Complexo Hospitalario Universitario de Santiago Recruiting
Santiago De Compostela, Galicia, Spain, 15706
Contact: Jose Martinez Sande, MD         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Nuria Rivas         
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Tim Betts         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Kristin Ruffner Abbott
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03882021    
Other Study ID Numbers: ABT-CIP-10275
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Recurrence
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes