Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
ISOLATION
1 other identifier
observational
500
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2020
CompletedFirst Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMay 5, 2020
May 1, 2020
3.2 years
April 8, 2020
May 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Time to recurrence of AF or atrial arrhythmia after the blanking period
24 months
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
Disease progression to persistent or permanent AF.
24 months
Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.
12 months
Use of antiarrhythmic drugs (AADs) one year after ablation.
12 months
- +1 more secondary outcomes
Interventions
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.
Eligibility Criteria
All eligible patients scheduled for AF ablation of at the MUMC+ and Radboudumc will be asked to participate in this cohort study.
You may qualify if:
- years of age or older;
- Documented atrial fibrillation;
- Scheduled for AF ablation or redo AF ablation;
- Able and willing to provide written informed consent.
You may not qualify if:
- Serious patient condition before ablation;
- Physically or mentally unable to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht Universitylead
- Maastricht University Medical Centercollaborator
- Radboud University Medical Centercollaborator
Study Sites (2)
Radboudumc
Nijmegen, Gelderland, 6525 GA Nijmegen, Netherlands
Maastricht UMC+
Maastricht, Limburg, 6229 HX, Netherlands
Related Publications (1)
Betz K, Verhaert DVM, Gawalko M, Hermans ANL, Habibi Z, Pluymaekers NAHA, van der Velden RMJ, Homberg M, Philippens S, Hereijgers MJM, Vorstermans B, Simons SO, den Uijl DW, Chaldoupi SM, Luermans JGLM, Westra SW, Lankveld T, van Steenwijk RP, Hol B, Schotten U, Vernooy K, Hendriks JM, Linz D. Atrial fibrillation-specific refinement of the STOP-Bang sleep apnoea screening questionnaire: insights from the Virtual-SAFARI study. Clin Res Cardiol. 2023 Jun;112(6):834-845. doi: 10.1007/s00392-023-02157-9. Epub 2023 Feb 11.
PMID: 36773038DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ulrich Schotten, MD PhD
Maastricht University, departments of physiology and cardiology
- STUDY CHAIR
Kevin Vernooy, MD PhD
Maastricht UMC+ and Radboudumc, department of cardiology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 13, 2020
Study Start
March 5, 2020
Primary Completion
May 1, 2023
Study Completion
May 1, 2024
Last Updated
May 5, 2020
Record last verified: 2020-05