Atrial Fibrillation Trial, Recruiting NCT05164107 Sponsor: Kardium Inc. Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT05164107
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 are scheduled to have a catheter ablation procedure for atrial fibrillation (AF), with a confirmed AF diagnosis within the past 12 months before enrolling.
  • People who have had one previous ablation procedure to isolate the pulmonary veins (using cryo, radiofrequency, or pulsed field techniques) may also be considered for this trial.
  • People who are between 18 and 75 years of age (inclusive).

Who may not be able to join:

  • People who have medical reasons that would prevent them from safely undergoing open heart surgery if needed.
  • People who are currently a patient in an Intensive Care Unit.
  • People who have an active widespread infection in the body (sepsis).
  • People who have had any previous ablation procedure in either the left or right chamber of the heart (confirm with trial site, as this interacts with the repeat ablation inclusion criterion above).
  • People who have received a heart transplant, or who are waiting for a heart transplant or other heart surgery.
  • People who have certain implanted cardiac devices that could interfere with the trial equipment, such as a device used to close a hole between the upper heart chambers, or a device that blocks the left atrial appendage.
  • People who have mitral valve prolapse or other significant heart valve problems, except for mild to moderate mitral valve leakage.
  • People with moderate to severe heart failure (classified as New York Heart Association Class III or IV).
  • People with a history of a blood clot-related event, including stroke or a mini-stroke (TIA).
  • People with a history of a bleeding disorder.
  • People with a known sensitivity or allergic reaction to anesthesia or muscle-relaxing medications used during procedures.
  • People who are currently on long-term steroid treatment (not including occasional use of inhaled steroids for breathing conditions).
  • People who have had a heart attack within the past three months.
  • People who have a significant blockage in the heart's electrical conduction system (second or third degree AV block).
  • People whose heart's pumping function is significantly reduced (left ventricular ejection fraction below 35%).
  • People who have unstable chest pain (unstable angina).

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 23 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: Motol and Homolka University Hospital, V Úvalu 84/1, 150 00 Prague 5, Czech Republic

Phone: +1 (604) 248 8891

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
Kardium Inc.
Registry
ClinicalTrials.gov
Start date
8 December 2021
Est. completion
1 May 2027

Where this trial is recruiting

🇨🇿 Czechia

Primary endpoints

Rate of subjects presenting with primary safety events which are device- or procedure-related

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: 23 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