Status:
NOT_YET_RECRUITING
Diagnostic Electrical Cardioversion for Explaining Patient's AF and HF Symptoms
Lead Sponsor:
M. Rienstra
Collaborating Sponsors:
Martini Hospital Groningen
University Medical Center Groningen
Conditions:
Atrial Fibrillation (AF)
Heart Failure (HF)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: The co-existence of Atrial Fibrillation (AF) and Heart Failure (HF) is associated with increased morbidity, mortality, and hospital admissions, significantly contributing to healthcare bur...
Eligibility Criteria
Inclusion
- Male or female patients with age ≥ 18 years
- Diagnosis of HF ≥90 days prior to screening NYHA class ≥ 2 on guideline-directed medical therapy.
- ECG-confirmed AF/Atrial flutter at screening
- Received oral anti-coagulants for ≥ 3 weeks (DOAC, vitamin K antagonists with an INR between 2 and 3) prior to screening
- Patients eligible for both treatment strategies judged by the investigator and physician.
- Provide written dated informed consent for participation prior to trial admission.
Exclusion
- A potential patient who meets any of the following criteria will be excluded from participation in this study:
- Inability to understand and sign informed consent form
- Hospitalization for acute HF or worsening HF ≤ 3 months prior to screening
- Heart rate during AF/ atrial flutter ≥ 110 bpm, despite optimal rate control therapy at screening
- Paroxysmal or permanent AF/atrial flutter
- Previous left atrial ablation or surgery ≤ 3 months prior to screening
- Planned catheter ablation at time of screening
- AF due to a reversible cause (e.g. post-operative AF, hyperthyroidism)
- 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)
- Presence of (or scheduled for) mechanical assist device or heart transplantation
- Patients with complex congenital heart disease, up to the discretion of the investigator.
- Patients with current echocardiographic evidence of severe aortic-, mitral-, tricuspid- or pulmonary- valve disease (either stenosis or regurgitation)
- Patients with an intracardiac thrombus
- Expected life span from time of enrolment of ≤1 year, as assessed by the clinician
- Patient currently enrolled in another randomized clinical trial
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT07000942
Start Date
August 1 2025
End Date
December 1 2027
Last Update
June 3 2025
Active Locations (1)
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1
UMCG
Groningen, Provincie Groningen, Netherlands, 9713 GZ