Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

— ISOLATION  

Official title:

Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342312
• Other study ID #: NL70787.068.19
• Status: Recruiting
• Start date: March 5, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2020
• Source: Maastricht University
• Contact: Dominique VM Verhaert, MD
• Phone: +31 24 30 92470
• Email: dominique.verhaert[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older;

• Documented atrial fibrillation;

• Scheduled for AF ablation or redo AF ablation;

• Able and willing to provide written informed consent.

Exclusion criteria

• Serious patient condition before ablation;

• Physically or mentally unable to provide written informed consent.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal
• Atrial Fibrillation, Persistent

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht	Limburg
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University	Maastricht University Medical Center, Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ablation success	Ablation success is defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.; Atrial arrhythmias are AF, atrial tachycardia (AT) and non-isthmus dependent atrial flutter (AFl), lasting more than 30 seconds, documented on ECG or Holter monitoring.	12 months
Secondary	Time to recurrence of AF or atrial arrhythmia after the blanking period		24 months
Secondary	Early recurrences of AF or atrial arrhythmia, defined as any episode of AF AT or non-isthmus dependent AFl during the blanking period.		3 months
Secondary	Disease progression to persistent or permanent AF.		24 months
Secondary	Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.		12 months
Secondary	Use of antiarrhythmic drugs (AADs) one year after ablation.		12 months
Secondary	Number of veins with pulmonary vein reconnection at redo procedure.		24 months