Spanish Registry of Redo Procedures Following Pulmonary Vein Ablation by Pulsed Field Ablation Technology: RESET-PFA

NCT07185412 | Not Yet Recruiting

• 1 other identifier: PI24/545
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

RESET-PFA 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 kinds of atrial arrhythmias and of all Adverse Events in the study population will be collected. The purpose of this study is to prospectively evaluate during time a large population of patients with an indication for ablation of AF, collecting data on procedural success in the acute and medium- to long-term follow-up. The primary objective of the study is the determination of up to 10 clinical and procedural parameters predicting a repeat ablation procedure after the blanking period in patients that had undergone an AF ablation with pulsed field ablation through a standard of care pathway.

Conditions

Cardiac Arrhythmia; Atrial Fibrillation; Pulsed Field Ablation

Keywords

Pulsed Field Ablation; Atrial fibrillation; Pulmonary vein isolation; Redo procedure; Mapping system

Outcome Measures

Primary Outcomes (2)

• Title: Predictive Value of Procedural Workflow Parameters for Repeat Ablation

  Association between specific procedural variables during the index procedure (e.g., number of PFA applications per vein, lesion validation method, total procedure time, voltage and activation map characteristics) as potential predictors of repeat ablation procedures and pulmonary vein isolation durability. Pulmonary vein isolation status will be assessed by electro-anatomical mapping systems in the repeat ablation procedure. The incidence of patients with isolated/not isolated pulmonary veins will be correlated with each procedural variable of the index procedure (number of PFA applications per vein, lesion validation method, total procedure time, voltage and activation map characteristics). All variables will be assessed individually and by multivariable logistic regression to establish odds ratio values.

  Index procedure through 12-month follow-up

• Predictive Value of Baseline Clinical Characteristics for Repeat Ablation

  Association individual baseline characteristics (e.g., age, sex, AF type, history of cardiac comorbidities, antiarrhythmic therapy) as potential predictors of repeat ablation procedures and pulmonary vein isolation durability. Pulmonary vein isolation status will be assessed by electro-anatomical mapping systems in the repeat ablation procedure. The incidence of patients with isolated/not isolated pulmonary veins will be correlated with baseline characteristics of the patient. All variables will be assessed individually and by multivariable logistic regression to establish odds ratio values.

  12 months post-index ablation

Secondary Outcomes (12)

• Percentage of patients free from any clinical arrhythmia and use of Type I or Type III antiarrhythmic medication

  12 months post-index ablation

• Rate of Repeat Ablation Procedure After Blanking Period

  12 months post-index ablation

• Durability of Pulmonary Vein Isolation at Repeat Procedure

  At time of repeat ablation (if performed within 12 months)

• Technical workflow variables of the PFA Procedure Over Time

  Measured during index procedure

• Electroanatomical Voltage Characteristics as Predictors of Arrhythmia Recurrence

  12 months post-index ablation

Study Arms (1)

AF ablation

Patients with standard indications to AF ablation

Device: Pulsed Field ablation: Ablation to treat atrial fibrillation

Interventions

Pulsed Field ablation: Ablation to treat atrial fibrillation DEVICE

Pulsed Field Ablation

AF ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients, clinically indicated for AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information

You may qualify if:

• Patients with an indication to a pulsed-field ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU or per physician discretion
• Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center or such consent will be provided by a legal representative, if required by local law or regulation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Unidad de Arritmias. Departamento de Cardiología. Hospital Universitario Lozano Blesa.

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Javier Ramos Maqueda, MD, PhD

CONTACT

0034615382731; javierramos.iias@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Arrhythmia Unit at Lozano Blesa University Clinical Hospital

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)