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Atrial FibrillationNCT05381805

ISOLATION 2.0: a Multicenter Clinical Care and Research Platform

An observational study of Atrial Fibrillation, run by Maastricht University Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Atrial Fibrillation
How many people
1,500 participants
Where
No sites listed yet
Study dates
1 Aug 2022to 1 Aug 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients from two hospitals in the Netherlands with documented AF, referred for AF ablation.

Who may be able to join

  • 18 years of age or older;
  • Documented atrial fibrillation;
  • Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
  • Able and willing to provide written informed consent.

Who cannot join

  • Conditions preventing the patient from adhering from the study protocol;
  • Emergency procedures.
  • A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:
  • Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
  • Severe allergic reaction against body surface electrodes
  • A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:
Show all 15Show fewer
  • Status after esophageal or gastric surgery
  • A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:
  • Contraindication to MRI
  • A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:
  • Prior catheter or surgical AF ablation.
  • Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):
  • Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
  • Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
  • Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zarina Habibi, MD contact

+31-43-3881200

ablatie.onderzoek@gmail.com

Dominique Verhaert, MD contact

ablatie.onderzoek@gmail.com

About this study

Official title: Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform

Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. The aim is to create a clinical characterization platform for patients scheduled for AF ablations with the purpose to optimize health care processes and related translational research.

Read the detailed description

Study design: Prospective cohort study and research platform of patients referred for AF ablation. Clinical characteristics and results of routine tests and procedures before, during and after AF ablation are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, and questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

Keywords
Ablation, Pulmonary Vein Isolation
Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ablation success

    Freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.

    Measured: 12 months

Secondary outcomes (16)

  1. Time to recurrence of AF or other atrial arrhythmia after the blanking period.

    Time to recurrence of AF or other atrial arrhythmia after the blanking period of 3 months.

    Measured: 3 to 24 months

  2. Early recurrences of AF or other atrial arrhythmia

    Defined as any episode of documented arrhythmia during the blanking period, defined as within 3 months

    Measured: 0 to 3 months

  3. Number of participants with disease progression to persistent or permanent AF.

    Disease progression to persistent or permanent AF. Persistent AF is defined as AF that lasts longer than 7 days. Permanent AF can't be corrected with treatments.

    Measured: 0 to 24 months

  4. Use of antiarrhythmic drugs (AADs) one year after ablation.

    Use of antiarrhythmic drugs (AADs) one year after ablation

    Measured: 0 to 24 months

  5. Interleukin 6 (IL-6) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  6. Pro-brain natriuretic peptide 2 (pro-BNP2) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  7. Fibroblast growth factor 23 (FGF-23) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  8. Dickkopf-related protein 3 (DKK-3) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  9. Angiopoietin 2 (ANG-2) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  10. Endothelial cell-specific molecule 1 (ESM-1) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  11. Insulin-like growth factor-binding protein 7 (IGFBP-7) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  12. Bone morphogenetic protein 10 (BMP-10) level

    Change in circulating biomarker for substrate quantification.

    Measured: 0 to 24 months

  13. Redo procedures

    Defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal.

    Measured: 0 to 24 months

  14. Number of veins with pulmonary vein reconnection at redo procedure.

    Number of veins with pulmonary vein reconnection at redo procedure.

    Measured: 0 to 24 months

  15. Major adverse cardiovascular events (MACE).

    Major adverse cardiovascular events (MACE).

    Measured: 0 to 24 months

  16. Procedure time

    Defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths).

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

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
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05381805
Sponsor's protocol ID
NL80761.068.22
Status last verified
May 2022
First submitted
7 Apr 2022
Last updated
19 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Maastricht University Medical Center.

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 15 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: opening soon, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zarina Habibi, MD (+31-43-3881200, ablatie.onderzoek@gmail.com), 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 NCT05381805.

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 19 May 2022.

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