NCT05005143|Unknown
Improved Procedural Workflow For Catheter Ablation Of Paroxysmal AF With High Density Mapping System And Advanced Technology
DELETE AF
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DELETE AF
Sponsor study identifier
observational
200
0 countries
N/A
Study Start
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
DELETE AF is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected. The purpose of this study is to demonstrate a low rate of clinical atrial arrhythmias recurrence with an improved procedural workflow for catheter ablation of paroxysmal AF, using the most advanced point-by-point RF ablation technology in a multicenter setting. The primary objective of the study is the rate of success at the medium-long term follow-up after PVI in a population of consecutive patients undergoing paroxysmal AF ablation. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2021
Actual (reported)August 13, 2021
Actual (reported)September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number and percentage of patients with clinical atrial arrhythmia recurrences
The primary outcome measure of this study is to estimate, after 12-months from the procedure, the number and the percentage of patients with documented clinical atrial arrhythmia recurrences. Arrhythmias in the definition are any AF, atrial flutter, or atrial tachycardia episode, continuous for \>30 seconds, as recorded by any post-ablation ECG modality. Arrhythmia recurrences within the first 3 months (blanking period) are classified as early recurrences and will not be considered procedural failure
12 months
Acute procedural success of AF ablation
Within 30 minutes after ablation procedure
Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation
12 months
Procedural ablation parameters
Intraoperative
Rate of adverse events and complications during procedure and follow up
12 months for adverse events during follow up and intraoperative for acute adverse events
Estimate costs related to the use of health care resources
12 months
Patients with standard indications to paroxysmal AF ablation
All consecutive patients, clinically indicated for paroxysmal AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information.
Solimene F, Stabile G, Ramos P, Segreti L, Cauti FM, De Sanctis V, Maggio R, Ramos-Maqueda J, Mont L, Schillaci V, Malacrida M, Garcia-Bolao I. Improved procedural workflow for catheter ablation of paroxysmal AF with high-density mapping system and advanced technology: Rationale and study design of a multicenter international study. Clin Cardiol. 2022 Jun;45(6):597-604. doi: 10.1002/clc.23806. Epub 2022 Apr 21.
Ignacio Garcia-Bolao
Department of Cardiology and Cardiac Surgery, Clínica Universidad de Navarra
First Submitted
August 5, 2021
First Posted
August 13, 2021
Study Start
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2022
Estimated (date passed)Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 13, 2021
Record last verified: 2021-08
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