Atrial Fibrillation Trial, Recruiting NCT07349121 Sponsor: Boston Scientific Corporation Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT07349121
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 whose doctor has determined they need treatment with both the FARAPULSE™ pulse field ablation system and a WATCHMAN FLX™ Pro or WATCHMAN FLX™ left atrial appendage closure device, based on their hospital's standard care guidelines.
  • People who are willing and able to give their informed consent to participate.
  • People who are willing and able to attend all required study visits and tests at an approved study centre.
  • People aged 18 or older, or who have reached the legal age of consent under their state and national laws.

Who may not be able to join:

  • People who have previously had an ablation procedure for atrial fibrillation.
  • People whose atrial fibrillation is caused by electrolyte imbalances, thyroid disease, alcohol use, or other reversible or non-heart-related causes.
  • People whose left atrial appendage (a small pouch in the heart) has already been surgically closed or removed.
  • People whose left atrial appendage shape or size is not suitable for the closure device.
  • People with a known or suspected benign tumour in the heart called an atrial myxoma.
  • People with a blood clot inside the heart.
  • People who have had surgery to repair a hole between the upper chambers of the heart, or who already have a device in place to close such a hole.
  • People who have a mechanical (artificial) heart valve in any position in the heart.
  • People who had a heart attack within the 90 days before joining the study.
  • People who had a stroke or a temporary stroke-like episode (sometimes called a "mini-stroke") within the 90 days before joining the study.
  • People who have a planned electrical heart rhythm reset procedure within 30 days after the closure device is implanted.
  • People whose doctor has determined that accessing their blood vessels for the procedure would not be possible.
  • People for whom a catheter-based procedure through the skin would not be suitable, due to body size, heart structure, or certain birth-related abnormalities of the heart or major blood vessels.
  • People with any active ongoing health conditions such as an infection, a bleeding disorder, or unstable chest pain.
  • People who cannot take blood-thinning medication in the short term for reasons unrelated to atrial fibrillation.
  • People who are pregnant or planning to become pregnant.
  • People whose doctor believes they have a life expectancy of one year or less.
  • People who are currently taking part in another research study or registry that would interfere with this trial — unless the other registry is a government-required registry or a purely observational registry with no treatments involved (each case would need to be reviewed by the study sponsor to determine suitability).

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 22 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: +1 612 819 4540

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
Boston Scientific Corporation
Registry
ClinicalTrials.gov
Start date
18 June 2026
Est. completion
1 December 2028

Where this trial is recruiting

🇭🇷 Croatia 🇫🇷 France 🇪🇸 Spain

Primary endpoints

Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events; Primary Efficacy Endpoint (PEE): Acute Treatment 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: 22 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