Atrial Fibrillation (AF)E-TEAMNCT07385417
Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
A study testing AF Ablation in people with Atrial Fibrillation (AF), run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial summary
The proposed pilot study is a prospective, randomized, single-center feasibility study, enrolling 200 patients with symptomatic paroxysmal AF. Per protocol, 100 patients will undergo a FARAPULSE electroporation PVI and 100 patients will receive standard AF medical treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- AF Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 12 Apr 2023to 12 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seeking emergency (E) treatment including emergency room (ER) presentation
- Paroxysmal AF diagnosed according to current ESC guidelines
- 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.
- Age between 18 and 80 years
- Left atrial size, LA < 55mm
- Left ventricular ejection fraction, EF >50%
- Patients able to provide informed consent and willing to comply with all pre-, post- and follow up requirements as per study protocol -
Who cannot join
- Currently participating in an interventional (drug, device, biologic, etc.) clinical trial
- Any disease that limits life expectancy to less than one year
- Contraindications for PVI
- Contraindication for AAD therapy
- Active systemic infection
- Thrombocytosis, thrombocytopenia
Show all 25Show fewer
- Known pre-existing hemi-diaphragmatic paralysis
- Any untreated or uncontrolled hyperthyroidism or hypothyroidism
- Reduced immune function or otherwise at high risk for infection per physician discretion
- Active malignancy or history of chemotherapy or radiation treatment
- Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months before the eligibility assessment
- Instable angina pectoris
- Primary pulmonary hypertension
- Any condition contraindicating chronic anticoagulation
- Any cerebral ischemic event (strokes or TIAs) which occurred within the 3 months before the consent date
- Presence of any cardiac prosthetic valves
- Left atrial diameter > 55 mm (anteroposterior) by TTE
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis (identified by CT or MRI and defined as at least 70% reduction of the PV diameter)
- Endocarditis, pericarditis or pericardial effusion
- Pregnant or breastfeeding women or women of childbearing potential not on adequate birth control.
- Substance abuse
- Unwilling to follow the study protocol and to attend follow-up visits
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60431
Boris Schmidt, Dr., +4969945028 ext. 110, b.schmidt@ccb.de
Boris Schmidt, Dr.
About this study
The proposed pilot study is a prospective, randomized, single-center feasibility study, enrolling 200 patients with symptomatic paroxysmal AF. Per protocol, 100 patients will undergo a FARAPULSE electroporation PVI and 100 patients will receive standard AF medical treatment.
Prior enrollment, all patients will be informed on the risk and benefits of the PVI procedure as well as the medical treatment. In addition, particular information on the rationale of the study, including a detailed risk/benefit analysis, will be provided to all patients.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- AF Ablation
- Keywords
- Electroporation Treatment for Early AF Management in Heart Failure with preserved Ejection Fraction (HFpEF) Pilot Study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF AblationProcedure or surgery
Also called Medication or ECV
Atrial fibrillation ablation
| Study group | Role | What they receive |
|---|---|---|
| AF Ablation with electroporation | Active comparator | Patient in this arm will receive AF-Ablation Receives: Procedure: AF Ablation |
| best medical AF treatment including rhythm and rate control (n=100) | No intervention | In this group patients reeive anti arrhythmia medication or ECV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
composite of cardiovascular hospitalization, death, systemic embolism, stroke and emergency (E) treatment for cardiovascular reason.
Measured: within the study duration of 1 Year
Secondary outcomes (1)
Secondary Endpoint
major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thromboembolic events, atrio-esophageal fistula, death
Measured: Within one year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start12 Apr 2023
- Primary completion12 Apr 2026 (estimated)
- Study completion12 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Chun, Professor, Principal investigator, MVZ CCB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385417
- Sponsor's protocol ID
- 20221013 E-Team V.2
- Acronym
- E-TEAM
- Status last verified
- Jan 2026
- First submitted
- 30 Nov 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
- ClinicalTrials.gov ID
- NCT07385417
- Acronym / sponsor ID
- E-TEAM / 20221013 E-Team V.2
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Electroporation Treatment for Early AF Management in Heart Failure with preserved Ejection Fraction (HFpEF) Pilot Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 12 Apr 2026 (estimated)
- Study completion
- 12 Apr 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed pilot study is a prospective, randomized, single-center feasibility study, enrolling 200 patients with symptomatic paroxysmal AF. Per protocol, 100 patients will undergo a FARAPULSE electroporation PVI and 100 patients will receive standard AF medical treatment.
Prior enrollment, all patients will be informed on the risk and benefits of the PVI procedure as well as the medical treatment. In addition, particular information on the rationale of the study, including a detailed risk/benefit analysis, will be provided to all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF Ablation with electroporation | Active comparator | Procedure: AF AblationPatient in this arm will receive AF-Ablation |
| best medical AF treatment including rhythm and rate control (n=100) | No intervention | –In this group patients reeive anti arrhythmia medication or ECV |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Seeking emergency (E) treatment including emergency room (ER) presentation
- Paroxysmal AF diagnosed according to current ESC guidelines
- 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.
- Age between 18 and 80 years
- Left atrial size, LA < 55mm
Key exclusion criteria (25 listed)
- Currently participating in an interventional (drug, device, biologic, etc.) clinical trial
- Any disease that limits life expectancy to less than one year
- Contraindications for PVI
- Contraindication for AAD therapy
- Active systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF AblationAlso: Medication or ECVAtrial fibrillation ablation | Procedure or surgery | AF Ablation with electroporation |
Primary outcome
Primary Endpoint
Time frame: within the study duration of 1 Year
composite of cardiovascular hospitalization, death, systemic embolism, stroke and emergency (E) treatment for cardiovascular reason.
1 secondary outcome
Secondary Endpoint
Time frame: Within one year study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julian Chun, Professor principal investigator
MVZ CCB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF Ablation in people with Atrial Fibrillation (AF), run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julian Chun, Professor (+49 69 945028 ext. 0, j.chun@ccb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: within the study duration of 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.