Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of clinical trial is to compare AF ablation to pharmacological rhythm management (being rate or rhythm control) in AF patients with signs of atrial cardiomyopathy (as defined by left atrial volume index \>34 ml/m2) The main objective it aims to answer is to determine whether AF ablation compared to pharmacological rhythm management in ACMP patients with AF reduces the incidence of the composite primary endpoint of CV death and first CV hospitalization/urgent visit.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
View:
• Confirmed ACMP (LAVI \>34 ml/m2)
• ECG-confirmed AF
• Age: 65-80 years old
• Patients eligible for both treatment strategies judged by the treating physician signed and dated informed consent prior to admission to the trial
Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
Contact Information
Primary
Michiel Rienstra, Prof. dr.
m.rienstra@umcg.nl
+31503616161
Backup
Nick L van Vreeswijk, Drs.
nickvanvreeswijk@gmail.com
0624678451
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2029-07-25
Participants
Target number of participants: 604
Treatments
Experimental: AF ablation
These patients will undergo Pulmonary vein isolation (PVI) (only)
Active_comparator: Pharmacological rhythm management
These patients will take rate control medication. If this therapy fails, pharmacological rhythm control and AF ablation are 2nd and 3rd line options respectively within this arm,
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen