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
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects enrolled will undergo the same mapping and ablation protocol.|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Success post blanking period through 12 months using different definitions [ Time Frame: 12 months ]
- Freedom from symptomatic AF/AFL/AT after removal from antiarrhythmic drug therapy
- 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
- Freedom from atrial fibrillation, atrial flutter and atrial tachycardia Survival analysis will be conducted to analyze time-to-event variables.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Krista Hicksfirstname.lastname@example.org|
|Contact: Karolien Timmermansemail@example.com|
|Kepler Universitätsklinikum GmbH||Recruiting|
|Linz, Upr Aus, Austria, 4021|
|Contact: Clemens Steinwender, MD, Prim.|
|FN U sv. Anny v Brno||Recruiting|
|Brno, Moravia-Silesia, Czechia, 656 91|
|Contact: Zdenek Starek, MD, Ph.D|
|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|
|Villeurbanne, Rhone, France, 69626|
|Contact: Herve Poty, MD|
|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|
|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|
|Universitair Medische Centrum Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: Yuri Blaauw, MD|
|Hospital de Santa Cruz||Recruiting|
|Carnaxide, Lisbon, Portugal, 2799-523|
|Contact: Pedro Adragao, Prof. Dr.|
|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|
|John Radcliffe Hospital||Recruiting|
|Oxford, United Kingdom, OX3 9DU|
|Contact: Tim Betts|
|Study Director:||Kristin Ruffner||Abbott|