UnknownNot Applicable

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

Netherlands380 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * • 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Biochemical factors in atrial biopsies and blood samples

Timeframe: 2.5 year follow up

Molecular factors in atrial biopsies and blood samples

Timeframe: 2.5 year follow up

Genetic factors in atrial biopsies and blood samples

Timeframe: 2.5 year follow up

Trial details

NCT IDNCT03124576

SponsorAcademisch Ziekenhuis Maastricht

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-10

Contact for this trial

Martijn Gilbers, Drs.

0031620606559 M.Gilbers@maastrichtuniversity.nl

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.