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Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation (ISOLATION)

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ClinicalTrials.gov Identifier: NCT04342312
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborators:
Maastricht University Medical Center
Radboud University
Information provided by (Responsible Party):
Maastricht University

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Fibrillation Paroxysmal Atrial Fibrillation, Persistent Procedure: Pulmonary vein isolation

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.
    Other Names:
    • atrial fibrillation ablation
    • AF ablation


Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Time to recurrence of AF or atrial arrhythmia after the blanking period [ Time Frame: 24 months ]
  2. 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 ]
  3. Disease progression to persistent or permanent AF. [ Time Frame: 24 months ]
  4. Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification. [ Time Frame: 12 months ]
  5. Use of antiarrhythmic drugs (AADs) one year after ablation. [ Time Frame: 12 months ]
  6. Number of veins with pulmonary vein reconnection at redo procedure. [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All eligible patients scheduled for AF ablation of at the MUMC+ and Radboudumc will be asked to participate in this cohort study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342312


Contacts
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Contact: Dominique VM Verhaert, MD +31 24 30 92470 dominique.verhaert@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA Nijmegen
Contact: Dominique VM Verhaert, MD         
Maastricht UMC+ Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Dominique VM Verhaert, MD         
Sponsors and Collaborators
Maastricht University
Maastricht University Medical Center
Radboud University
Investigators
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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
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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT04342312    
Other Study ID Numbers: NL70787.068.19
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University:
Pulmonary Vein Isolation
Cryoballoon ablation
Radiofrequency ablation
Atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes