Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation (PREDICTORS)

October 11, 2023 updated by: Centro Cardiologico Monzino

Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal Atrial Fibrillation Undergoing First Transcatheter Ablation Procedure of Atrial Fibrillation by Pulmonary Vein Isolation

From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter prospective and retrospective observational study aimed at examining the role of the left atrial substrate and other baseline clinical variables on the efficacy of transcatheter ablation in patients with paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation regardless of the power source and balloon or "point by point" catheters used.

The study will evaluate whether there are baseline clinical or electrophysiological features that can predict the success of transcatheter atrial fibrillation ablation even before it is performed, so as to assess which patients may actually benefit, and which patients should instead undergo more extensive ablative procedures in conjunction with pulmonary vein isolation to achieve an optimal success rate.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation

Description

Inclusion Criteria:

  • Patients with indication for AF ablation
  • Adequate anticoagulation therapy according to CHADs VASC

Exclusion Criteria:

  • patients who had already undergo an AF ablation procedure
  • Presence of intracavitary thrombus
  • Ejection fraction <35%
  • Pregnancy
  • Hematologic contraindications to ionizing radiation exposure
  • Congenital heart diseases
  • Cardiac Surgery < 1month
  • Uncontrolled heart failure
  • Valvular disease
  • Contraindications to general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective cohort
Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation
Other: Standard of care
All patients will undergo, as clinically indicated, AF ablation by pulmonary vein isolation achievable by radiofrequency, cryoenergy, or electroporation. All patients will preliminarily undergo electroanatomic mapping of the atrium by CARTO/Navx/Rhythmia system indifferently. Patients will be given follow-up visits at 3-6-12 months, during which any arrhythmic recurrences will be assessed
Retrospective cohort
Patients who underwent ablative procedure in the two years prior to the start of the study
Other: Data collection
There's no patient involvement. Data of patients who underwent ablative procedures two years before the start of the study will be retrospectively analyzed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess clinical and electrophysiological predictors of arrhythmic recurrence
Time Frame: through study completion, an average of 1 year
Evaluate the role of atrial disease, assessed by baseline electroanatomic mapping, age, gender, echocardiographic data, years from first AF episode, in predicting AF recurrence after AF ablation.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate acute and mid- to long-term efficacy, safety, and procedural timing of different technologies
Time Frame: through study completion, an average of 1 year
Evaluate mid and long term efficacy, safety, procedural timing between Cryo ablation, Pulsed Field Ablation, Radio Frequency ablation, point by point or single shot ablation of paroxysmal atrial fibrillation.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Investigators

  • Principal Investigator: Stefania Riva, MD, IRCCS Centro Cardiologico Monzino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCM 1981

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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