Atrial Fibrillation Trial, Recruiting NCT06157437 Sponsor: Hangzhou Dinova EP Technology Co., Ltd Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT06157437
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 18 years of age or older
  • People who have had at least one confirmed episode of a specific type of irregular heart rhythm called atrial flutter, recorded by a heart tracing (ECG or Holter monitor) in the 180 days before joining the trial — recordings from other hospitals are accepted
  • People who understand the purpose of the study, are willing to take part, sign a consent form, and agree to attend all required follow-up appointments

Who may not be able to join:

  • People who have previously had a procedure to treat atrial flutter in a specific area of the heart (called cavo-tricuspid isthmus ablation)
  • People with unstable angina (chest pain that is unpredictable or occurring at rest)
  • People whose atrial flutter is caused by an electrolyte imbalance, thyroid condition, or another reversible underlying cause
  • People who have had a heart attack, open-heart bypass surgery, or a procedure to open blocked arteries (such as a stent) within the past three months
  • People whose heart failure has been rated as severe (Grade III or IV on a standard medical scale) at the time of assessment
  • People who have an implanted heart device such as a defibrillator, cardiac resynchronisation device, or pacemaker
  • People who have had a recorded tumour, blood clot, or known clotting disorder in the heart or blood vessels within the past 90 days
  • People with serious structural heart problems — such as narrowing or malformation of the tricuspid heart valve, or other birth-related heart conditions — that would prevent the ablation procedure from being performed
  • People who have previously had a tricuspid heart valve replaced with a metal valve
  • People who have had a stroke, blood clot event, or a brief stroke-like episode (transient ischaemic attack) within the past six months
  • People who have a blood clot, tumour, or other abnormality in blood vessels that would interfere with placing a catheter or needle during the procedure
  • People with serious lung disease, high blood pressure in the lungs, or any lung condition causing abnormal oxygen levels or severe breathing difficulties
  • People for whom blood-thinning medication is not safe to use, or who have a history of abnormal clotting or bleeding
  • People with an active infection affecting the whole body
  • People with significantly reduced kidney function (creatinine levels more than twice the normal upper limit) or who have a history of kidney dialysis
  • People who are pregnant, breastfeeding, or unable to use contraception during the study period
  • People who are already participating in another clinical trial involving a different device or medication at the same time
  • People whose life expectancy is less than 12 months, for example due to advanced cancer
  • People who have any other condition or abnormality that the trial investigator considers would make participation unsuitable (confirm with trial site)

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 13 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: +8637158680341

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
Hangzhou Dinova EP Technology Co., Ltd
Registry
ClinicalTrials.gov
Start date
1 December 2023
Est. completion
30 June 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Acute procedural 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: 13 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