NCT07385417

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

November 30, 2023

Last Update Submit

January 29, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

Electroporation Treatment for Early AF Management in Heart Failure with preserved Ejection Fraction (HFpEF) Pilot Study

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint

    composite of cardiovascular hospitalization, death, systemic embolism, stroke and emergency (E) treatment for cardiovascular reason.

    within the study duration of 1 Year

Secondary Outcomes (1)

  • Secondary Endpoint

    Within one year study

Study Arms (2)

AF Ablation with electroporation

ACTIVE COMPARATOR

Patient in this arm will receive AF-Ablation

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

Interventions

AF AblationPROCEDURE

Atrial fibrillation ablation

Also known as: Medication or ECV
AF Ablation with electroporation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, 60431, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Julian Chun, Professor

    MVZ CCB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Chun, Professor

CONTACT

+49 69 945028j.chun@ccb.de

Boris Scmidt, Professor

CONTACT

+49 69 945028b.schmidt@ccb.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

February 4, 2026

Study Start

April 12, 2023

Primary Completion

April 12, 2026

Study Completion

April 12, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

DE(1)