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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF Ablation with electroporation | Active Comparator | Patient 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AF Ablation | Procedure | Atrial fibrillation ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | composite of cardiovascular hospitalization, death, systemic embolism, stroke and emergency (E) treatment for cardiovascular reason. | within the study duration of 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thromboembolic events, atrio-esophageal fistula, death | Within one year study |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julian Chun, Professor | Contact | +49 69 945028 | 0 | j.chun@ccb.de |
| Boris Scmidt, Professor | Contact | +49 69 945028 | 0 | b.schmidt@ccb.de |
| Name | Affiliation | Role |
|---|---|---|
| Julian Chun, Professor | MVZ CCB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardioangiologisches Centrum Bethanien | Recruiting | Frankfurt am Main | 60431 | Germany |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Version 2.1 | Oct 10, 2025 | Jan 29, 2026 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: E-Team Study Protocol V2.1 | Oct 13, 2022 | Oct 13, 2025 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |