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Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation

NCT04342312 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-05-05

No results posted yet for this study

Summary

Rationale:

Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty.

Objectives:

To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.

Study design:

Prospective registry of patients undergoing AF ablation. Clinical characteristics and results of routine tests are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

Study population:

Patients aged 18 years and older with documented AF, scheduled for AF ablation.

Main study endpoints:

Ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.

Conditions

Interventions

PROCEDURE

Pulmonary vein isolation

Participation in this study does not influence the choice of ablation technique. Usually, cryoballoon ablation is chosen for patients with paroxysmal AF and no previous ablations. Radiofrequency ablation is often used for redo procedures or for patients with persistent AF. Hybrid ablations are most applied in persistent AF patients. However, physicians may deviate from these standard approaches for a variety of reasons, including personal experience or preference.

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Maastricht University

    lead OTHER

Principal Investigators

  • Ulrich Schotten, MD PhD · Maastricht University, departments of physiology and cardiology

  • Kevin Vernooy, MD PhD · Maastricht UMC+ and Radboudumc, department of cardiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2023-05-01
Completion
2024-05-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342312 on ClinicalTrials.gov