Atrial Fibrillation Trial, Recruiting NCT06065124 Sponsor: University Medical Center Groningen Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT06065124
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with heart failure based on European heart specialist guidelines
  • Your heart is pumping at least 40% of its normal capacity (your doctor can check this)
  • You have scored a certain level on a specialist heart failure assessment called the HFA-PEFF score, either 5 or above, or between 2–4 combined with a positive stress test (confirm with trial site)
  • You are between 45 and 70 years old
  • Your Body Mass Index (BMI) — a measure of body weight relative to height — is between 32 and 40
  • You have a type of irregular heartbeat called atrial fibrillation (AF) that comes and goes or is persistent, and you are being treated with a strategy to restore normal heart rhythm
  • You are willing to take part in both treatment approaches being studied
  • You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • Your BMI is 40 or above, or below 32
  • You are unwilling or unable to sign a consent form
  • You have more than moderate leakage in your mitral or aortic heart valves
  • You have more than mild narrowing of your mitral or aortic heart valves
  • The ultrasound images of your heart are not clear enough for the required measurements (confirm with trial site)
  • You have had a heart attack, heart inflammation, a stroke, or any invasive heart procedure (such as heart surgery or a procedure to treat an irregular heartbeat) within the last 3 months
  • You are already scheduled to have a procedure to treat your atrial fibrillation (AF ablation)
  • You have a complex heart defect that you were born with
  • A specialist psychiatrist has advised against treatment due to unstable mental health conditions, such as severe depression, psychotic disorders, or serious personality disorders
  • You are unable to look after yourself or would not be able to make the lifestyle changes required after weight-loss (bariatric) surgery
  • You have a medical condition that means your life expectancy is less than 2 years
  • You have a condition that requires long-term use of anti-inflammatory medications
  • You are taking medication known to cause significant weight changes of more than 5 kg

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Michiel Rienstra, MD, PhD, University Medical Center Groningen

Phone: +31503611327

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
1 October 2027

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Hierarchical endpoint

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov