Electroanatomical Mapping Versus Fluoroscopy Based Pulmonary Vein Isolation by Means of PulseSelect Catheter in Patients With Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Durability of PVI
Study Overview
Brief Summary
Electroanatomical mapping (EAM) based pulmonary vein isolation (PVI) by means of PulseSelect catheter and deep sedation will be compared to fluoroscopy based pulmonary vein isolation in patients with atrial fibrillation in the acute and long term (2 months remapping).
Detailed Description
- Trial Population All patients with symptomatic paroxysmal or persistent AF scheduled for PVI
- Treatment Patients with AF will have to receive first oral anticoagulation for 3 weeks. Thereafter all patients will be randomized either to fluoroscopy-based or EAM-based PVI by means of the PulseSelect catheter. Transesophageal echocardiography will not be necessary prior to cardioversion of catheter ablation. Oral anticoagulation will be continued until the morning of the procedure and resumed on the evening after the intervention.
- Deep sedation Patients will be under deep sedation using boluses of midazolam, fentanyl, and propofol. Sedation will be initiated with an intravenous injection of a bolus of 1 to 2 mg midazolam plus 20 to 30 mg propofol. To maintain deep sedation, additional boluses of 10 to 20 mg propofol will be administered at intervals of at least 30 seconds.
- Ablation protocol One application (4 pulse trains) is delivered at each catheter position and a minimum of 8 applications should be completed for each vein, ensuring continuous and overlapping lesions (4 ostial and 4 antral) by rotating the catheter between ablations and flexing the sheath to create overlapping lesion segments. Electrode 5, always distally located, is used as a reference during 45 degrees rotation between each ostial and antral lesion.
EAM use facilitates overlapping and reduces the possibility for gaps. The highlighted fifth electrode is used as quick real-time reference and snapshots of the array immediately prior to pulse delivery as reference for planning subsequent ablation sites.
In both groups an additional set of 4 lesions inside the pulmonary veins will be performed initially before the ostial and antral lesions.
In half patients Carto 3 Prime® 3D-EAM system (Biosense Webster, Diamond Bar CA) system will be used for visualization of the PulseSelect catheter. Initially, a multipolar catheter (PentaRay®) will be used to map the left atrium pre-ablation.
During catheter manipulation, the investigators will visualize both the full array and highlight the fifth electrode to allow for easier and faster perception of the farthest, with regard to catheter shaft, ablation area. Input to the 3D-EAM will be interrupted during energy delivery to prevent malfunction. In cases of an extreme angle of the right inferior pulmonary vein, placement of the PulseSelect catheter in the bottom part of the vein without the guidewire inside the vein may be attempted by means of 3D-EAM and targeting the fifth electrode of the catheter.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ALL the following criteria must be fulfilled:
- •Male or female patients aged ≥18 and <80 years old.
- •Patients with paroxysmal or persistent AF requiring PVI.
- •Signed written informed consent by the patient for participation in the study and agreement to comply with the procedure and the follow-up schedule
Exclusion Criteria
- •Patients with previous AF ablations
- •EF<35%, CABG surgery within previous 3 months, TIA or stroke within previous 6 months
- •Patients were excluded if ineligible for treatment with oral anticoagulation.
Arms & Interventions
Fluoroscopy-based catheter ablation by means of PulseSelect catheter (Device)
In 20 patients, a fluoroscopy-based approach will be used for visualization of the PulseSelect catheter.
Intervention: Fluoro based pulmonary vein ablation (Device)
EAM-based catheter ablation by means of PulseSelect catheter (Device)
In 20 patients Carto 3 Prime® 3D-EAM system (Biosense Webster, Diamond Bar CA) system will be used for visualization of the PulseSelect catheter.
Initially, a multipolar catheter (PentaRay®) will be used to map the left atrium pre-ablation.
Intervention: EAM based Pulmonary Vein Isolation (Device)
Outcomes
Primary Outcomes
Durability of PVI
Time Frame: 2 to 3 months post index ablation
Durability of pulmonary vein isolation based on a remap procedure after a follow up of at least 2 months post index procedure (percentage of patients with all PVs isolated, percentage of PVs isolated)
PVI durability by means of a fluoroscopy-based or an EAM-based index procedure
Time Frame: 2 to 3 months post index ablation
Comparison of PVI durability according to fluoroscopy-based or EAM-based index procedure Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Identification of pulmonary vein isolation gaps acutely based on EAM
Time Frame: 2 to 3 months post index ablation
Mapping will be performed in all cases post PVI (either fluoroscopy-based or EAM-based)
Identification of pulmonary vein isolation gaps on remap
Time Frame: 2 to 3 months post index ablation
Remapping will be performed 2+ months post-index procedure
Secondary Outcomes
- Fluoroscopy time and dose(During index procedure)
- First pass pulmonary vein isolation(Index procedure)
- Durability of superior vena cava isolation(2-3 months post index procedure)
- Procedure time(During index procedure)
- Left atrial access time to sheath removal(During index procedure)
- Left atrial dwelling time(During index procedure)
Investigators
Tsiachris Dimitrios
Assistant Professor of Cardiology
University of Athens