Phase 4 Atrial Fibrillation Trial, Recruiting NCT05844501 Sponsor: Indiana University Condition: Atrial Fibrillation
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Phase 4 Atrial Fibrillation Trial, Recruiting

NCT05844501
Recruiting Phase 4

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 between 18 and 100 years of age (men or women)
  • People who have been confirmed by an ECG (heart tracing test) to have an irregular heart rhythm called atrial fibrillation (AF) and/or atrial flutter, and who are scheduled for a planned procedure called catheter ablation to treat it
  • People who are taking blood-thinning medication as recommended by current medical guidelines (in some lower-risk cases, a doctor may determine blood thinners are not needed)

Who may not be able to join:

  • Women who are able to become pregnant
  • People who have had unexplained fainting episodes in the past 6 months
  • People with a diagnosis of an overactive thyroid (thyrotoxicosis) that is currently active
  • People whose atrial fibrillation was caused by a temporary, non-heart-related condition
  • People with a diagnosis of acutely worsening heart failure (a sudden severe episode)
  • People whose heart pumping function is very low — specifically, a heart pumping strength (ejection fraction) of 20% or less
  • People with the most severe category of heart failure, known as New York Heart Association Class IV
  • People with severe liver disease (as measured by a medical scoring system called Child-Pugh, with a score of 10 or higher)
  • People who have had heart surgery in the past 2 months
  • People who are unable to take blood-thinning medication due to a medical reason, as documented by their treating doctor
  • People with certain abnormal heart electrical readings on an ECG taken within two weeks before the screening visit (confirm with trial site for specific values)
  • People whose resting heart rate is below 50 beats per minute during normal heart rhythm
  • People with a diagnosis of low blood pressure (hypotension)
  • People with a diagnosis of Wolff-Parkinson-White syndrome (a specific heart rhythm condition)
  • People who have previously had an allergic reaction to the medication ondansetron, or who have previously experienced a reaction called serotonin syndrome
  • People with a diagnosis of phenylketonuria (a rare inherited metabolic condition)
  • People with a diagnosis of congenital long QT syndrome (an inherited heart rhythm condition)
  • People currently taking both a beta-blocker and a specific type of blood pressure medication called a non-dihydropyridine calcium channel blocker at the same time
  • People with a history of a dangerous heart rhythm called torsades de pointes, or prolonged QT interval, caused by medication
  • People currently taking certain medications known to affect heart rhythm (a specific category called QT-prolonging drugs), with the exception of amiodarone and propafenone (confirm with trial site)
  • People currently taking certain medications that affect serotonin levels in the body, including antidepressants such as SSRIs and SNRIs, MAOIs, mirtazapine, lithium, tramadol, or other specified drugs including apomorphine, phenytoin, carbamazepine, oxcarbazepine, or rifampin
  • People with a heart pumping strength below 20% confirmed by a heart scan (echocardiogram) within 6 months before enrolment
  • People with a known allergy to adhesives (such as those used in medical patches or electrodes)
  • People who use neuromuscular stimulator devices (electrical devices that stimulate muscles or nerves)

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 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: James E Tisdale, PharmD, Purdue University

Phone: 317-880-5418

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
Phase 4
Registry
ClinicalTrials.gov
Start date
22 April 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Atrial fibrillation burden; Ventricular rate control; Ventricular rate control; Ventricular rate control; Ventricular rate control

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: 26 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