Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
Recruiting · NCT07385417 · Interventional (participants receive a specific treatment) · Lead sponsor: Cardioangiologisches Centrum Bethanien
View the official record on ClinicalTrials.gov →Interventions studied
AF Ablation
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Cardioangiologisches Centrum Bethanien - Frankfurt am Main, Germany
- Cardioangiologisches Centrum Bethanien - Frankfurt am Main, Germany