Status:
COMPLETED
The Deep Sedation for Ablation Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Atrial Fibrillation
Ablation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Catheter ablation (CA) is an established therapeutic option for patients with symptomatic atrial fibrillation (AF). During the procedure, patients are usually sedated and analgesized, most commonly by...
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia. In symptomatic patients, electroanatomic mapping aided catheter ablation (CA) is an established therapeutic option. The intervention may last se...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Informed consent as documented by signature
- Catheter ablation of atrial fibrillation at the Department of Cardiology, Inselspital Bern
Exclusion
- Contraindication to sedation by the electrophysiologist
- Contraindications to either propofol or dexmedetomidine sedation
- Contraindication for targeted controlled propofol infusion (BMI \> 35)
- American Society of Anesthesiologists (ASA) classification \> III
- Advanced heart block (second or third degree), if no pacemaker or internal cardioverter defibrillator is implanted
- Arterial hypotension (mean \< 80 mmHg)
- Severe heart failure (LVEF ≤ 30%)
- Indication for general anaesthesia
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03844841
Start Date
July 1 2019
End Date
December 31 2020
Last Update
January 25 2021
Active Locations (1)
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1
Department of Cardiology, University Hospital Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010