Atrial Fibrillation (AF), Heart Failure (HF) Atrial Fibrillation, Heart Failure
Conditions
Interventions
All study' subjects meeting the inclusion criteria and not meeting any exclusion criteria will be randomized in a 1:1 ratio to undergo either AV node ablation with CSP or AV node ablation with CRT imp
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1- Age 18 years or above. 2- Patient is diagnosed with AF and deemed not amenable for rhythm control. This diagnosis of AF will be demonstrated by at least one Electrocardiographs (ECG) showing AF that were performed within one year prior to enrollment. 3- Has history of stable heart failure (regardless left ventricular ejection fraction) and has a history of at least one HF related hospitalization or emergency room/urgent care visit within 2 years prior to enrollment, despite being on maximally tolerable guideline directed medical therapy. 4-Willing and capable to provide informed consent.
Exclusion criteria
Exclusion criteria: 1-NYHA functional class IV. 2-Severe concomitant non-cardiac disease. 3-Patient who require any cardiac surgical intervention. 4-Previously implanted pacing devices (pacemaker/ICD/CRT) with =40% pacing burden. 5-Any of the following within the 3 months prior to enrollment: myocardial infarction, unstable angina, percutaneous coronary intervention, stroke/TIA, significant bleeding, or pericarditis/effusions. 6- Coronary artery bypass surgery/atriotomy within 6 months prior to enrolment. 7-Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The hierarchical primary composite endpoint is the composite of all-cause mortality, HF hospitalization or unplanned/urgent HF visit, and =5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Major secondary endpoint: =5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. - Quality of life improvement (EQ-5D and AFEQT questionnaires). -HF hospitalization or unplanned/urgent HF visit. -Cardiovascular related hospitalization. -All-cause mortality. -Cardiovascular related mortality. | — |
Countries
France, Germany, Italy, Netherlands
Contacts
Public ContactM Rienstra
Universitair Medisch Centrum Groningen
Outcome results
None listed