New heart zapping tech tested for stubborn AFib
NCT ID NCT05408754
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two new devices that use energy pulses to treat persistent atrial fibrillation (a type of irregular heartbeat). 89 adults who had not responded to medication received a heart ablation procedure. The goal was to see if the devices are safe and can stop abnormal heart rhythms for at least a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pulsed field ablation and pulsed field cryoablation systems (devices that use energy to destroy heart tissue causing abnormal rhythms)
- What this could lead to
- If successful, this could provide a safer, more effective way to treat persistent atrial fibrillation, potentially reducing the need for long-term medication.
- What could go wrong
- This is an early, first-in-human study with only 89 participants, so results may not apply to everyone. There are risks of procedure-related 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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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89 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 to 80 years
- 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: IC 1 Male or female between the ages of 18 - 80 years IC 2 Currently scheduled for an ablation of symptomatic persistent (\> 7 days) atrial fibrillation within the past year documented by ECG or Continuous Holter monitoring IC 3 Refractory to at least one class I or III AAD. (Refractory defined as not effective or not tolerated) IC 4 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study IC 5 Willingness and ability to give an informed consent Exclusion Criteria: EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including but not limited to the identification of any atrial thrombus or evidence of sepsis EC 2 Continuous AF lasting longer than 12-months EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT EC 4 AF secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 5 Structural heart disease as described below: 1. Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE 2. Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening 3. NYHA Class III or IV heart failure documented within the previous 12-months 4. An implanted pacemaker or ICD 5. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG), 6. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve 7. Interatrial baffle, closure device, patch, or PFO occluder 8. Presence of a left atrial appendage occlusion device 9. Presence of any pulmonary vein stenting devices 10. Coronary artery bypass graft (CABG) or PTCA procedure within six (6) months prior to procedure 11. Unstable angina or ongoing myocardial ischemia 12. Myocardial infarction within the previous six (6) months prior to procedure 13. Moderate or severe mitral insufficiency or stenosis based on most recent TTE 14. Atrial myxoma 15. Significant congenital anomaly EC 6 BMI \> 40 EC 7 Any previous history of cryoglobulinemia (for those patients randomized to the PFCA arm) EC 8 History of blood clotting or bleeding disease EC 9 History of severe COPD requiring steroid use in the previous 12-months EC 10 History of severe sleep apnea (AHI \> 30) not currently treated with a CPAP machine or other mechanical device EC 11 Stroke or TIA within the last year. EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis EC 13 Pregnant or lactating (current or anticipated during study follow-up EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study EC 15 Any other conditions such as, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center that may lead to non-compliance with the protocol procedure or follow up
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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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Blackrock Health
Dublin, A94 E4X7, Ireland
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McGill University Health Centre (MUHC), Montreal General Hospital (MGH)
Montreal, Quebec, H3G 1A4, Canada
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Nemocnice Na Homolce
Prague, 150 30, Czechia
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Onze-Lieve-Vrouwziekenhuis (OLV)
Aalst, B-9300, Belgium
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St Antonius Ziekenhuis
Nieuwegein, 3435, Netherlands
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St George'S University Hospital
London, SW17 0QT, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation
- Suture device may get heart patients walking sooner after leg vein procedures
- Two ways to catch a hidden heart rhythm after stroke
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?