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Status unknownNCT03124576RACE V- WP 5Updated Jul 19, 2018

Reappraisal of Atrial Fibrillation: RACE-V - Work Package 5

An observational study in Atrial Fibrillation, sponsored by Academisch Ziekenhuis Maastricht. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Academisch Ziekenhuis Maastricht · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
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Study summary

In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.

For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.

Read the detailed description

An estimated 380 patients will be included

Four patient categories will be included enabling to study patients with different stages of AF progression;

  1. Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group),
  2. Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring,
  3. Patients with self-terminating atrial fibrillation at inclusion, and
  4. Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.
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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 380 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Academisch Ziekenhuis Maastricht is the lead sponsor of 22 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

380 patiënts undergoing elective open chest heart surgery.

Inclusion criteria

  • Age > 18 years;
  • Undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation;
  • Able and willing to sign informed consent for the registry;
  • Able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (ICD) with atrial leads)

Exclusion criteria

Exclusion Criteria:

    • Deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits.

      • Pregnancy.
      • Life expectancy of less than 2.5 years.
      • History of prior cardiac surgery or ablation for atrial fibrillation.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
380 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • control group

    Without history of atrial fibrillation/without newly developed atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder

    Device: Implantable loop recorder

  • group B

    Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder

    Device: Implantable loop recorder

  • group C

    Patients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring

    Device: Implantable loop recorder

  • group D

    Patients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring

    Device: Implantable loop recorder

Interventions

  • DeviceImplantable loop recorder

    Continuous rhythm monitoring Medtronic

    Also known as: Reveal LINQ™,Medtronic, ConfirmTM, St. Jude, BiomonitorTM, Biotronik

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What researchers measure

Primary outcomes

  1. Biochemical factors in atrial biopsies and blood samples

    Biochemical factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression

    Time frame: 2.5 year follow up

  2. Molecular factors in atrial biopsies and blood samples

    Molecular factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression

    Time frame: 2.5 year follow up

  3. Genetic factors in atrial biopsies and blood samples

    Genetic factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression

    Time frame: 2.5 year follow up

Secondary outcomes

  1. Atrial fibrillation burden

    Atrial fibrillation burden

    Time frame: 2.5 year follow up

  2. Number of atrial fibrillation episodes

    Number of atrial fibrillation episodes

    Time frame: 2.5 year follow up

  3. Duration of atrial fibrillation episodes

    Duration of atrial fibrillation episodes

    Time frame: 2.5 year follow up

  4. Major adverse cardiovascular and cerebrovascular events

    Major adverse cardiovascular and cerebrovascular events (i.e. death, stroke, myocardial infarction)

    Time frame: 2.5 year follow up

  5. First recurrent atrial fibrillation;

    First recurrent atrial fibrillation

    Time frame: 2.5 year follow up

  6. AF progression

    Self-terminating atrial fibrillation turning into non-self-terminating atrial fibrillation measured from ECGs and implantable loop recorders

    Time frame: 2.5 year follow up

  7. AF complexity

    Electrical atrial fibrillation complexity or signs of atrial conduction disturbances measured from ECGs

    Time frame: 2.5 year follow up

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03124576
Lead sponsor
Academisch Ziekenhuis Maastricht
Responsible party
J. G. Maessen (Prof. Dr., Academisch Ziekenhuis Maastricht) — Principal investigator
First posted
Apr 24, 2017
Start date
Nov 2016
Primary completion
Oct 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Jul 19, 2018

Study contacts

Martijn Gilbers, Drs.
Contact
M.Gilbers@maastrichtuniversity.nl
0031620606559
Jos Maessen, Prof. Dr.
principal investigator · Academisch Ziekenhuis Maastricht

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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