New heart procedure aims to zap AFib safely
NCT ID NCT06765356
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called the Farapulse system, which uses electrical pulses to treat atrial fibrillation (AFib), a common heart rhythm problem. Researchers will enroll 275 adults with AFib who are already scheduled for a catheter ablation procedure. The goal is to see if the system can safely and effectively restore normal heart rhythm and reduce the need for future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Farapulse Catheter System (FARAWAVE catheter and FARASTAR generator)
- What this could lead to
- If successful, this could provide a safer, more effective way to treat atrial fibrillation and reduce the need for repeat procedures or long-term medication.
- What could go wrong
- This is a single-arm study without a comparison group, so results may not prove superiority over existing treatments. Risks include procedural complications like bleeding or heart damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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275 people
The number who actually took part.
- Started
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Apr 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 or older * Diagnosed with atrial fibrillation with or without concomitant atrial flutter by ECG at some point in the past, and by any criteria (ECG or clear symptoms within the past year) * Previous catheter ablation for other arrhythmias (including left-sided ablation, but not for AF) is allowed * Planned for a clinically-indicated catheter ablation procedure for managing paroxysmal or persistent atrial fibrillation in accordance with the following recommendations in the ACC/AHA/ACCP/HRS guidelines * In patients with symptomatic AF in whom antiarrhythmic drugs have been ineffective, contraindicated, not tolerated or not preferred, and continued rhythm control is desired, catheter ablation is useful to improve symptoms.(Class 1) * In selected patients (generally younger with few comorbidities) with symptomatic paroxysmal AF in whom rhythm control is desired, catheter ablation is useful as first-line therapy to improve symptoms and reduce progression to persistent AF. (Class 1) * In patients (other than younger with few comorbidities) with symptomatic paroxysmal or persistent AF who are being managed with a rhythm-control strategy, catheter ablation as first-line therapy can be useful to improve symptoms. (Class 2a) * In selected patients with asymptomatic or minimally symptomatic AF, catheter ablation may be useful for reducing progression of AF and its associated complications. (Class 2b) * In patients who present with a new diagnosis of HFrEF and AF, arrhythmia-induced cardiomyopathy should be suspected, and an early and aggressive approach to AF rhythm control is recommended. (Class 1) * In appropriate patients with AF and HFrEF who are on GDMT, and with reasonable expectation of procedural benefit, catheter ablation is beneficial to improve symptoms, QOL, ventricular function, and cardiovascular outcomes. (Class 1) * In appropriate patients with symptomatic AF and HFpEF with reasonable expectation of benefit, catheter ablation can be useful to improve symptoms and improve QOL. (Class 2a) * In athletes who develop AF, catheter ablation with PVI is a reasonable strategy for rhythm control because of its effectiveness and low risk of detrimental effect on exercise capacity. (Class 2a) * Have in place or have plans for implantation of a loop recorder, pacemaker or cardiac defibrillator capable of recording atrial rhythm (e.g. dual chamber) (ideally, this implantable device would be present for at least 4 weeks pre-PFA) * Able and willing to provide written consent and comply with all testing and follow-up requirements Exclusion Criteria: * Documented "active" left atrial thrombus (patients may later undergo the procedure if this is no longer present, eg, with anticoagulation treatment) * Reversible cause of AF (e.g., post-operative, thyroid disorder, etc.) * Conditions that make an AF ablation procedure unlikely to be successful (e.g., advanced infiltrative cardiomyopathies like amyloid, severe mitral stenosis or regurgitation, and cor pulmonale) * PCI/STEMI within the prior 1 month * Active systemic infection or sepsis * Contraindication to all anticoagulation * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude an ablation procedure * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial. * Life expectancy or other disease processes likely to limit survival to less than 12 months * Currently, enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
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Cardiology Associates Medical Group
Ventura, California, 93003, United States
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Mount Sinai Morningside
New York, New York, 10025, United States
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Naples Comprehensive Health
Naples, Florida, 34102, United States
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Ohio Health Research Institute
Columbus, Ohio, 43214, United States
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Sentara Health Research Center
Virginia Beach, Virginia, 23455, United States
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The Mount Sinai Hospital
New York, New York, 10029, United States
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Trident Medical Center
North Charleston, South Carolina, 29406, United States
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UPMC Pinnacle Hospitals
Harrisburg, Pennsylvania, 17101, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- Pulsed electric fields take aim at irregular heartbeats
- Can a new drug stop long atrial fibrillation episodes?
- Which ablation method wins for tough atrial fibrillation cases?