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Active Not Recruiting
NCT04906668
ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients With Persistent AF
Conditions: Atrial Fibrillation
Sex: All
Ages: 75 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 196
Sponsor: St. Josefs-Hospital Wiesbaden GmbH
Location: Universitätsklinikum Innsbruck Innsbruck
Summary
As patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ABLATE versus PACE is a prospective, randomized clinical trial comparing pacemaker implantation with AV node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent AF aged 75 years and older.
Eligibility Criteria
Inclusion Criteria:
* Persistent AF according to current ESC guideline (2020)
* Symptoms EHRA classification II - IV despite guideline indicated medical therapy
* Age ≥ 75 years
* Capability of giving written informed consent
Exclusion Criteria:
* impaired systolic left ventricular function (ejection fraction \< 50%)
* High-grade (III°) left cardiac valvular disease
* pre-implanted pacemaker
* bradycardia-indication for pacemaker
* Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
* contraindication for PVI or pacemaker-implantation
* contraindication for oral anticoagulation
* body-mass-index BMI \> 40 kg/m2
* inability to give written informed consent
* concomitant participation in another registered trial
* life expectancy \< 12 months
* reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)
Source: ClinicalTrials.gov (NCT04906668). StuddyBuddy aggregates publicly available trial information.