Improved Procedural Workflow For Catheter Ablation Of Paroxysmal AF With High Density Mapping System And Advanced Technology

NCT05005143 | Unknown

• 1 other identifier: PI_2021/41
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiac Arrhythmias; Atrial Fibrillation

Keywords

Catheter ablation; Arrhythmias; Mapping system; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (1)

Paroxysmal AF ablation

Patients with standard indications to paroxysmal AF ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• History of recurrent symptomatic paroxysmal AF (PAF) with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.
• Patients with an indication to an ablation procedure with 3D high-density mapping system according to current international and local guidelines (and future revisions), existing IFU and per physician discretion
• Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.
• Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.

You may not qualify if:

• Patients who have persistent or long-standing persistent AF (\>1 AF episodes lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year)
• Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
• Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
• Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
• Life expectancy ≤ 12 months per physician judgment.
• Patients who have undergone a previous cardiac ablation within 90 days prior to enrollment;
• Unrecovered/unresolved Adverse Events from any previous invasive procedure;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
• Left atrial size \> 60 mm diameter on echocardiogram
• Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
• AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
• History of prior surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Related Publications (1)

• 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.

  PMID: 35446440 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ignacio Garcia-Bolao

  Department of Cardiology and Cardiac Surgery, Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Canales Ruiz

CONTACT

+34948255400; ucicec@unav.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: August 13, 2021

Record last verified: 2021-08