Ascension Texas Cardiovascular
Austin, Texas, 78705, United States
NCT Number: NCT07788989
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts more than 7 days and doesn't stop on its own).
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Austin, Texas, 78705, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
Time frame: Up to 7 days post-procedure
PAEs include early onset AEs such as:
Time frame: Day 61 up to Day 365 post-procedure
Percentage of residual AA burden will be calculated as AA episodes over the monitoring time during the effectiveness evaluation period. Participants with residual AA burden less than or equal to (<=) 0.1% and freedom from the following failure modes will be considered a success
Time frame: Baseline to 12 months post-procedure
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.
Time frame: Day 61 up to Day 365 post-procedure
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or >=60 minutes on ILR arrhythmia monitoring) during the post-blanking period will be reported.
Time frame: Day 61 up to Day 365 post-procedure
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or >=30 seconds on ILR arrhythmia monitoring) during the post-blanking period.
Time frame: Day 61 up to Day 365 post-procedure
Number of participants with residual AA burden <=0.1% in the post-blanking period, without any additional failure modes will be reported.
Time frame: Day 61 up to Day 365 post-procedure
Percentage of residual AA burden in the post-blanking period without any additional failure modes will be reported.
Contact information is provided by the study sponsor or research team.
Andrew Oliver
CONTACT
Josiah Gillespie
CONTACT
Biosense Webster, Inc.
Industry
High-Density Atrial Mapping After Pulsed Field Ablation (PFA): Development of an Algorithm to Predict Atrial Fibrillation (AF) Burden in Participants With Paroxysmal AF (PAF) and Persistent AF (PsAF) Treated With the VARIPULSE™ PFA Catheter
Acronym: SPECTRA-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.
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