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New electric pulse procedure could tame AFib in heart failure patients

NCT ID NCT07385417

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study is testing a new procedure called electroporation ablation (using the FARAPULSE system) to treat atrial fibrillation in 200 people who also have heart failure with preserved ejection fraction. Half will get the procedure, half will get standard medical care. The goal is to see if the procedure reduces hospitalizations, strokes, and other serious events. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
electroporation ablation (FARAPULSE procedure)
What this could lead to
If successful, this could offer a more effective way to control atrial fibrillation in people with heart failure, potentially reducing hospital visits and complications.
What could go wrong
This is a small, early pilot study, so results may not apply broadly. The procedure carries risks like bleeding, nerve injury, or heart damage, and it's unclear if it will outperform standard medication.

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

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Seeking emergency (E) treatment including emergency room (ER) presentation 2. Paroxysmal AF diagnosed according to current ESC guidelines 3. Diagnosis of HFpEF according to ESC guidelines 2021 (clinical symptoms, EF\>50%, objective evidence of functional abnormality: LV diastolic dysfunction, NT-proBNP (non acute setting): sinus rhythm: 125pg/ml or AF: 365pg/ml, vs. acute HF: \>450 pg/ml if aged \<55 years, \>900 pg/ml if aged between 55 and 75 years and \>1800 pg/ml if \>75ys. 4. Age between 18 and 80 years 5. Left atrial size, LA \< 55mm 6. Left ventricular ejection fraction, EF \>50% 7. Patients able to provide informed consent and willing to comply with all pre-, post- and follow up requirements as per study protocol - Exclusion Criteria: 1. Currently participating in an interventional (drug, device, biologic, etc.) clinical trial 2. Any disease that limits life expectancy to less than one year 3. Contraindications for PVI 4. Contraindication for AAD therapy 5. Active systemic infection 6. Thrombocytosis, thrombocytopenia 7. Known pre-existing hemi-diaphragmatic paralysis 8. Any untreated or uncontrolled hyperthyroidism or hypothyroidism 9. Reduced immune function or otherwise at high risk for infection per physician discretion 10. Active malignancy or history of chemotherapy or radiation treatment 11. Prior left atrial ablation or surgical procedure (including left atrial appendage closures) 12. Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months before the eligibility assessment 13. Instable angina pectoris 14. Primary pulmonary hypertension 15. Any condition contraindicating chronic anticoagulation 16. Any cerebral ischemic event (strokes or TIAs) which occurred within the 3 months before the consent date 17. Presence of any cardiac prosthetic valves 18. Left atrial diameter \> 55 mm (anteroposterior) by TTE 19. Presence of any pulmonary vein stents 20. Presence of any pre-existing pulmonary vein stenosis (identified by CT or MRI and defined as at least 70% reduction of the PV diameter) 21. Endocarditis, pericarditis or pericardial effusion 22. Pregnant or breastfeeding women or women of childbearing potential not on adequate birth control. 23. Substance abuse 24. Unwilling to follow the study protocol and to attend follow-up visits \-

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cardioangiologisches Centrum Bethanien

    RECRUITING

    Frankfurt am Main, 60431, Germany

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