Trials / Completed
CompletedNCT03747263
Individualized Approach vs. Fixed Approach
Individualized Approach vs. Fixed Approach Utilizing the Novel Arctic Front Advanced Pro Cryoballoon for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Observational Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University of Luebeck · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the current study is to assess differences regarding the acute efficacy, safety, procedural duration, radiation exposure and long-term success of the novel AFA-Pro in combination of an individualized shortened ablation protocol containing a reduced freezing time to the standard approach of a fixed ablation protocol in patients with symptomatic PAF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Catheter ablation | Electrophysiology studies are performed during conscious sedation using boluses of midazolam and fentanyl and a continuous infusion of propofol. Vital parameters are continuously monitored. One 7F standard diagnostic catheter is positioned inside the coronary sinus (CS) via the femoral vein. One 8,5-F sheath is advanced to the left atrium (LA). After transseptal catheterization, intravenous heparin is administered to target an activated clotting time of ≥300 seconds. PV angiographies are obtained for each PV and PV recordings are registered at baseline in SR. The 8.5F transseptal sheath (TS) is changed over the wire for a 12F steerable TS. |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2020-05-01
- Completion
- 2020-05-07
- First posted
- 2018-11-20
- Last updated
- 2020-05-21
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03747263. Inclusion in this directory is not an endorsement.