PulseSelect Based Pulmonary Vein Isolation and Ablation in Patients With Atrial Fibrillation

NCT ID: NCT07035288

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-07-10

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.

The procedural end point will be bidirectional conduction block of all pulmonary veins after a 20-minute observation period. If reconnection of a pulmonary vein is observed, repeat ablation will be performed until block is achieved.

• Follow up/EP Study All patients will be re-assessed 2 months post ablation. Changes of therapy will not be performed during the blind period of 2 months. Clinical atrial tachyarrhythmias recurrence, need for electrical cardioversion and need for hospitalization will also be recorded. A 24-hour holter will be performed 2 months post ablation.

In all patients Carto 3 Prime® 3D-EAM system (Biosense Webster, Diamond Bar CA) system will be used for remapping of the left atrium 2 months post-ablation. All veins will be reassessed for bidirectional block to confirm continued electrical isolation. Any gaps identified will be targeted and ablated with Navistar STSF ablation catheter (Biosense Webster, Diamond Bar CA).

To assess for PV reconnection and the location of gaps, a high-density voltage map will be performed with the color display range set to 0.20 to 0.50 mV as well as to 0.10 to 0.30 mV to accentuate the border zone between healthy tissue and scar for visual identification of gaps. Gaps will be classified according to each PV quarter (anterior, superior, posterior, inferior). Stored fluoroscopy and electroanatomical pamming images from the primary procedure will be used for analysis. In case of PV reconnection, we will search for the earliest activation site as a potential location of a gap. The location of gaps will be defined by PV reisolation during ablation or, in case of multiple gaps, a clear change in PV activation sequence.

In case of aberrant PV anatomy, such as a common left trunk, all PVs were assessed individually for durable isolation and are considered individual PVs in the analyses.

Study follow-up schedule: All patients will be re-assessed at least 2 months post ablation. Changes of therapy will not be performed during the blind period of 2 months. A follow up visit will be performed at least 2 months post ablation. Clinical atrial tachyarrhythmias recurrence, need for electrical cardioversion and need for hospitalization will be recorded. A 24-hour holter will also be performed 2 months post ablation. Likewise, an off-line detailed EAM analysis will be performed post remapping focused on accurate gap identification (if any).

Conditions

Atrial Fibrillation (AF); Catheter Ablation; Pulmonary Vein Isolation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Fluoro based pulmonary vein ablation

Intervention Type: DEVICE

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to Fluoroscopy by means of the PulseSelect catheter.

Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

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.

Group Type: ACTIVE_COMPARATOR

EAM based Pulmonary Vein Isolation

Intervention Type: DEVICE

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to EAM by means of the PulseSelect catheter.

Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

Interventions

EAM based Pulmonary Vein Isolation

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to EAM by means of the PulseSelect catheter.

Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

Intervention Type: DEVICE

Fluoro based pulmonary vein ablation

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to Fluoroscopy by means of the PulseSelect catheter.

Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

Intervention Type: DEVICE

Other Intervention Names

Catheter Ablation

Eligibility Criteria

Inclusion Criteria

• ALL the following criteria must be fulfilled:

1. Male or female patients aged ≥18 and <80 years old.

2. Patients with paroxysmal or persistent AF requiring PVI.

3. 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

1. Patients with previous AF ablations

2. EF<35%, CABG surgery within previous 3 months, TIA or stroke within previous 6 months

3. Patients were excluded if ineligible for treatment with oral anticoagulation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Atrial Fibrillation Solutions

INDUSTRY

Sponsor Role: collaborator

Tsiachris Dimitrios

OTHER

Sponsor Role: lead

Responsible Party

Tsiachris Dimitrios

Assistant Professor of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital

Athens, Attica, Greece

Countries

Greece

References

Kordalis A, Tsiachris D, Antoniou CK, Doundoulakis I, Tsioufis K. Verification of persistent pulmonary vein isolation with electroanatomical mapping 3 months after ablation using a novel PFA platform. Hellenic J Cardiol. 2024 Nov 19:S1109-9666(24)00232-X. doi: 10.1016/j.hjc.2024.11.002. Online ahead of print. No abstract available.

Reference Type: RESULT

PMID: 39566605 (View on PubMed)

Tsiachris D, Antoniou CK, Doundoulakis I, Kordalis A, Stefanadis C, Tsioufis K. Single-center initial experience with a new pulsed-field ablation system: pulmonary vein isolation lesions and beyond. Future Cardiol. 2024;20(14):739-746. doi: 10.1080/14796678.2024.2413829. Epub 2024 Nov 19.

Reference Type: RESULT

PMID: 39560013 (View on PubMed)

Other Identifiers

4895-18/03/2025

Identifier Type: -

Identifier Source: org_study_id