NCT Number: NCT03882021
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Kepler Universitätsklinikum GmbH, Linz, UPR AUS, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: the end of the 3-month blanking period to 12 months after initial ablation procedure
Percentage of participants with freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia rafter removal from AADs. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
Single procedure clinical success was 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. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
Freedom from atrial fibrillation, atrial flutter and atrial tachycardia recurrence. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: During procedure, an average of 160 minutes
Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates.
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.
Time frame: Baseline
LA volume will be summarized with the mean with standard deviation.
Time frame: Baseline
LA diameter will be summarized with the mean with standard deviation.
Time frame: 12 months
Number of adverse events, including any device-, procedure-, or death-related events (serious or non-serious).
Abbott Medical Devices
Industry
Acronym: WAVE-MAP AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05085860
Arrhythmias, Cardiac, Atrial Fibrillation
Ottawa, Ontario, Canada
View Trial DetailsNCT06223789
Arrhythmias, Cardiac, Atrial Arrhythmia
Birmingham, Alabama, United States
View Trial DetailsNCT06175234
Arrhythmias, Cardiac, Atrial Fibrillation
Prague, Czechia
View Trial DetailsNCT06014996
Arrhythmias, Cardiac, Atrial Fibrillation
Beijing, Beijing Municipality, China
View Trial Details