Atrial Fibrillation Trial, Recruiting NCT07281521 Sponsor: CardioFocus Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT07281521
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 diagnosed with recurrent symptomatic paroxysmal atrial fibrillation (AF that starts and stops on its own) or persistent atrial fibrillation (AF that continues unless treated), with documented proof of episodes within the past 12 months
  • People with persistent AF who have medical records showing either a 24-hour ECG recording of continuous AF, two separate rhythm recordings taken at least 7 days apart, or a history of at least two electrical shock procedures (cardioversions) to restore normal heart rhythm, all within the past 12 months
  • People who have tried at least one heart rhythm medication for AF and either found it did not work well enough or could not tolerate its side effects
  • People aged 18 to 75 years old on the day of enrollment
  • People for whom a heart ablation procedure is considered appropriate according to medical guidelines or the trial site's practice
  • People who are willing and able to give informed consent and commit to all required check-ups and follow-up visits for the full length of the study

Who may not be able to join:

  • People who have had AF continuously for more than one year (known as long-standing persistent AF)
  • People whose AF is caused by a treatable or non-heart-related condition, such as a thyroid problem, electrolyte imbalance, or alcohol use
  • People who have previously had a heart ablation procedure or heart surgery, including procedures involving a device or closure on the left atrial appendage, or any valve surgery
  • People who are planning to have a left atrial appendage closure, a permanent pacemaker, or an implantable heart defibrillator placed at any point during the study
  • People who already have a permanent pacemaker or implantable heart defibrillator that cannot be safely adjusted during the ablation procedure
  • People who cannot stop taking heart rhythm medications for reasons unrelated to AF, including those with Wolff-Parkinson-White syndrome or a history of a serious heart rhythm problem called ventricular tachycardia
  • People who have a filter device in the large vein that carries blood to the heart (IVC filter)
  • People who have a patch or baffle between the upper chambers of the heart
  • People who have stents or narrowing in the pulmonary veins (the blood vessels connecting the lungs to the heart)
  • People who already have paralysis of one side of the diaphragm (the muscle used for breathing)
  • People who have had a closure procedure for a hole between the heart's chambers
  • People who have a benign heart tumour called an atrial myxoma
  • People who have an artificial or biological replacement heart valve
  • People with significant heart valve disease, as assessed by the trial doctor
  • People with a history of inflammation around the heart (pericarditis)
  • People with a history of rheumatic heart disease
  • People who have had a blood clot or stroke within the 6 months before the ablation procedure, or who have a blood clot inside the heart at the time of the procedure
  • People who have experienced, within the 3 months before the ablation procedure: a heart attack, unstable chest pain, a coronary artery procedure, heart surgery, hospitalisation for heart failure, a stroke or mini-stroke, serious bleeding requiring surgery, fluid around the heart, or surgery involving the heart's chambers
  • People with the most severe stage of heart failure (classified as NYHA Class IV)
  • People whose heart pumping function has been measured at 35% or less within the 6 months before enrollment
  • People with a condition causing abnormal thickening of the heart muscle (hypertrophic cardiomyopathy)
  • People with high blood pressure in the lungs not caused by another condition (primary pulmonary hypertension)
  • People with significant or symptomatic low blood pressure
  • People with abnormal platelet counts (either too high or too low)
  • People who cannot take or are unwilling to take blood-thinning medication
  • People who cannot have a CT scan or MRI
  • People with an allergy to contrast dye used in scans that cannot be managed with pre-treatment medication
  • People who are pregnant, breastfeeding, or of childbearing potential and not using a reliable form of contraception or abstinence
  • People who are already participating in another research study that could affect this trial's results
  • People with serious untreated medical conditions that could interfere with participation, including: organ transplant recipients or those being assessed for transplant; severe lung disease; kidney disease with significantly reduced function, a history of dialysis, or kidney transplant; active or recently treated cancer (within the past 24 months); serious oesophageal (food pipe) conditions or uncontrolled reflux disease; an active infection; a significant psychological condition that the trial doctor determines would prevent meeting study requirements; or a life expectancy of less than one year

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 15 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

Phone: +32 498 774371

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
CardioFocus
Registry
ClinicalTrials.gov
Start date
27 February 2023
Est. completion
1 August 2026

Where this trial is recruiting

🇭🇷 Croatia 🇨🇿 Czechia

Primary endpoints

Primary Safety Endpoint - Rate of Primary Serious Adverse Events; Primary Effectiveness Endpoint - Acute Procedure Success

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: 15 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