Status:
ACTIVE_NOT_RECRUITING
ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients With Persistent AF
Lead Sponsor:
St. Josefs-Hospital Wiesbaden GmbH
Collaborating Sponsors:
The German Heart Foundation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
75-99 years
Phase:
NA
Brief 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 tri...
Detailed Description
Atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk. In case of ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04906668
Start Date
May 1 2021
End Date
April 30 2027
Last Update
September 17 2025
Active Locations (12)
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1
Universitätsklinikum Innsbruck
Innsbruck, Austria
2
Kerckhoff-Klinik Bad Nauheim
Bad Nauheim, Germany
3
Vivantes Klinikum am Urban
Berlin, Germany
4
Universitätsklinikum Essen
Essen, Germany