Diagnostic Electrical Cardioversion for Explaining Patient's AF and HF Symptoms

Launched by M. RIENSTRA · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a procedure called diagnostic electrical cardioversion (ECV) can help doctors better understand and treat symptoms in patients who have both atrial fibrillation (AF) and heart failure (HF). These two conditions often overlap, making it hard for doctors to know which one is causing a patient's symptoms. The goal of the trial is to see if using ECV leads to more changes in treatment over three months compared to standard care, which does not include ECV. Researchers hope this will improve patients' quality of life and heart function.

To participate in this trial, patients must be at least 18 years old, have been diagnosed with heart failure for at least 90 days, and have a confirmed diagnosis of atrial fibrillation. Participants will be randomly assigned to either receive the ECV procedure or continue with their usual treatment. All participants will complete questionnaires about their quality of life and have heart tests before and after the study to measure any changes. It's important to know that this trial follows national guidelines, so no additional risks are expected beyond standard care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients with age ≥ 18 years
• • 2. Diagnosis of HF ≥90 days prior to screening NYHA class ≥ 2 on guideline-directed medical therapy.
• • 3. ECG-confirmed AF/Atrial flutter at screening
• • 4. Received oral anti-coagulants for ≥ 3 weeks (DOAC, vitamin K antagonists with an INR between 2 and 3) prior to screening
• • 5. Patients eligible for both treatment strategies judged by the investigator and physician.
• • 6. Provide written dated informed consent for participation prior to trial admission.
• Exclusion Criteria:
• A potential patient who meets any of the following criteria will be excluded from participation in this study:
• • 1. Inability to understand and sign informed consent form
• • 2. Hospitalization for acute HF or worsening HF ≤ 3 months prior to screening
• • 3. Heart rate during AF/ atrial flutter ≥ 110 bpm, despite optimal rate control therapy at screening
• • 4. Paroxysmal or permanent AF/atrial flutter
• • 5. Previous left atrial ablation or surgery ≤ 3 months prior to screening
• • 6. Planned catheter ablation at time of screening
• • 7. AF due to a reversible cause (e.g. post-operative AF, hyperthyroidism)
• • 8. Recent acute coronary syndrome, stroke/transient ischemic attack or cardiac intervention (≤90 days). Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical)
• • 9. Presence of (or scheduled for) mechanical assist device or heart transplantation
• • 10. Patients with complex congenital heart disease, up to the discretion of the investigator.
• • 11. Patients with current echocardiographic evidence of severe aortic-, mitral-, tricuspid- or pulmonary- valve disease (either stenosis or regurgitation)
• • 12. Patients with an intracardiac thrombus
• • 13. Expected life span from time of enrolment of ≤1 year, as assessed by the clinician
• • 14. Patient currently enrolled in another randomized clinical trial