Atrial FibrillationISOLATIONNCT04342312
Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Maastricht University at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
- What is being tested?
- Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesNetherlands
- Study dates
- 5 Mar 2020to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All eligible patients scheduled for AF ablation of at the MUMC+ and Radboudumc will be asked to participate in this cohort study.
Who may be able to join
- 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.
Who cannot join
- Serious patient condition before ablation;
- Physically or mentally unable to provide written informed consent.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Maastricht UMC+
Maastricht, Limburg, 6229 HX
Dominique VM Verhaert, MD
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA Nijmegen
Dominique VM Verhaert, MD
About this study
Official title: Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study
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.
Read more
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.
- Being tested
- Pulmonary vein isolation
- Keywords
- Pulmonary Vein Isolation, Cryoballoon ablation, Radiofrequency ablation, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
Also called atrial fibrillation ablation, AF ablation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Time to recurrence of AF or atrial arrhythmia after the blanking period
Measured: 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.
Measured: 3 months
Disease progression to persistent or permanent AF.
Measured: 24 months
Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.
Measured: 12 months
Use of antiarrhythmic drugs (AADs) one year after ablation.
Measured: 12 months
Number of veins with pulmonary vein reconnection at redo procedure.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start5 Mar 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Schotten, MD PhD, Study chair, Maastricht University, departments of physiology and cardiologyKevin Vernooy, MD PhD, Study chair, Maastricht UMC+ and Radboudumc, department of cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342312
- Sponsor's protocol ID
- NL70787.068.19
- Acronym
- ISOLATION
- Status last verified
- May 2020
- First submitted
- 8 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bijvoet GP, Hermans BJM, Linz D, Luermans JGLM, Maesen B, Nijveldt R, Mihl C, Vernooy K, Wildberger JE, Holtackers RJ, Schotten U, Chaldoupi SM. Optimal Threshold and Interpatient Variability in Left Atrial Ablation Scar Assessment by Dark-Blood LGE CMR. JACC Clin Electrophysiol. 2024 Oct;10(10):2186-2197. doi: 10.1016/j.jacep.2024.05.017. Epub 2024 Jul 10.
PubMed 39001763Betz 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.
PubMed 36773038
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04342312
- Acronym / sponsor ID
- ISOLATION / NL70787.068.19
- Keywords
- Pulmonary Vein Isolation, Cryoballoon ablation, Radiofrequency ablation, Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Radboud University Medical Center
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All eligible patients scheduled for AF ablation of at the MUMC+ and Radboudumc will be asked to participate in this cohort study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Serious patient condition before ablation;
- Physically or mentally unable to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolationAlso: atrial fibrillation ablation, AF ablationParticipation 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. | Procedure or surgery | – |
Primary outcome
Ablation success
Time frame: 12 months
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.
6 secondary outcomes
Time to recurrence of AF or atrial arrhythmia after the blanking period
Time frame: 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.
Time frame: 3 months
Disease progression to persistent or permanent AF.
Time frame: 24 months
Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.
Time frame: 12 months
Use of antiarrhythmic drugs (AADs) one year after ablation.
Time frame: 12 months
Number of veins with pulmonary vein reconnection at redo procedure.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Derived from this study: PubMed 39001763Bijvoet GP, Hermans BJM, Linz D, Luermans JGLM, Maesen B, Nijveldt R, Mihl C, Vernooy K, Wildberger JE, Holtackers RJ, Schotten U, Chaldoupi SM. Optimal Threshold and Interpatient Variability in Left Atrial Ablation Scar Assessment by Dark-Blood LGE CMR. JACC Clin Electrophysiol. 2024 Oct;10(10):2186-2197. doi: 10.1016/j.jacep.2024.05.017. Epub 2024 Jul 10.
- Derived from this study: PubMed 36773038Betz 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.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Schotten, MD PhD study chair
Maastricht University, departments of physiology and cardiology
Kevin Vernooy, MD PhD study chair
Maastricht UMC+ and Radboudumc, department of cardiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Maastricht University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique VM Verhaert, MD (+31 24 30 92470, dominique.verhaert@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablation success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342312, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.