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Recruiting NCT07385417

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

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AF Ablation.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure AF Ablation
    Atrial fibrillation ablation

Primary outcome measures

  • Primary Endpoint [Time frame: within the study duration of 1 Year]
Secondary outcome measures (1)
  • Secondary Endpoint [Time frame: Within one year study]

Eligibility criteria

Inclusion criteria

  • 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 -

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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Cardioangiologisches Centrum Bethanien — Frankfurt am Main

Identifiers

NCT: NCT07385417 · 20221013 E-Team V.2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗