Atrial Fibrillation Trial, Recruiting NCT04685317 Sponsor: Malini Madhavan Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT04685317
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:

  • Adults aged 18 or older who are scheduled to have a heart rhythm procedure (called ablation — using radiofrequency, pulsed field, or cryo-balloon methods) to treat atrial fibrillation (an irregular heartbeat), in line with current medical guidelines.
  • People whose atrial fibrillation causes symptoms and has either not responded to, or could not be tolerated with, certain heart rhythm medications — or who are being considered for ablation before trying those medications.
  • People who are willing and able to give their agreement to take part in the trial (informed consent).
  • People whose blood vessel anatomy in the chest and neck area has been assessed by a CT scan and found to be suitable for the procedure.

Who may not be able to join:

  • People whose blood vessel anatomy is not suitable for the trial's special device — for example, due to poor blood flow in the right arm, or because the major blood vessels leading to the brain have significant blockages (over 70%), twisting, widening, tearing, or bulging.
  • People who have had a stroke or a temporary stroke-like episode (sometimes called a "mini-stroke") within the past six months.
  • People who have a carotid artery condition (in the neck) that requires treatment within the next six weeks.
  • People who are unable or unwilling to give their agreement to take part.
  • People who are pregnant.
  • People with a known history of dementia.
  • People with a known allergy or sensitivity to nickel-titanium (a metal used in some medical devices).
  • People who have implanted devices in their body that are not safe for MRI scans, including certain heart devices such as pacemakers or defibrillators.
  • People who have a blood clot in a specific part of the heart (the left atrium) — all patients are routinely checked for this before the procedure using ultrasound imaging.
  • People whose atrial fibrillation is caused by a treatable underlying condition, such as an overactive thyroid.

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 20 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: Malini Madhavan, MBBS, Mayo Clinic

Phone: (507) 255-0774

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
Malini Madhavan
Registry
ClinicalTrials.gov
Start date
7 March 2023
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incident of overt and covert CNS injury 7 days post AF ablation; Incident of overt and covert CNS injury 90 days post AF ablation

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: 20 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