Atrial Fibrillation Trial, Recruiting NCT06557616 Sponsor: Medinice S.A. Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT06557616
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:

  • People who have given written agreement to take part in the study.
  • People aged 18 or older.
  • People who have been assessed as needing mitral valve surgery (either repair or replacement), with or without a procedure to close a small pouch in the heart called the left atrial appendage.
  • People who have had a confirmed diagnosis of a heart rhythm condition called atrial fibrillation (where the heart beats irregularly) — either in episodes or continuously — for at least 3 months before surgery, not caused by a short-term illness.

Who may not be able to join:

  • People who have not given written agreement to take part.
  • People who do not meet the inclusion criteria listed above.
  • People for whom a freezing-based heart tissue treatment (cryoablation) is medically unsuitable (confirm with trial site).
  • People who are currently breastfeeding, pregnant, or planning to become pregnant within 6 months of receiving the study treatment.
  • People who have certain other health conditions that may themselves cause atrial fibrillation, such as an uncontrolled thyroid disorder, a serious active infection, a specific type of adrenal gland tumour, or a significant imbalance of minerals in the blood.
  • People who have significant calcium build-up in a specific chamber of the heart (the left atrium).
  • People who have previously had heart surgery.
  • People whose heart's left atrium is very enlarged — measuring more than 10 cm in any direction on an ultrasound scan of the heart.
  • People who are currently taking part in another clinical trial.
  • People who are currently receiving a type of treatment called active biological therapy.
  • People who need emergency surgery.
  • People whose life expectancy is less than 12 months.
  • People where, in the trial doctor's judgement, participation would carry unreasonable risk or make it difficult to follow the study procedures.

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 16 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: Tomasz Hrapkowicz, MD PhD, Silesian Centre for Heart Diseases

Phone: +48-519-136-533

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
Sponsor
Medinice S.A.
Registry
ClinicalTrials.gov
Start date
3 July 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Percentage of patients with no documented recurrence of atrial fibrillation on continuous 48h Holter ECG recording during 6-month follow-up.; Incidence of adverse events and serious adverse events related to the use of the

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: 16 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