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Simplified Pulmonary Vein Isolation Using singLe Catheter and IntraCardiac Echocardiography

NCT04923009 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-01-10

No results posted yet for this study

Summary

Ablation for paroxysmal atrial fibrillation (PAF) by means of pulmonary vein isolation (PVI) is the principal method for the treatment of PAF. Usually, PVI is confirmed by recording PV potentials (PVP) from the circular catheter placed at the ostium of PV. However, newer and faster methods became avialable. The only currently available technique which can visualize LA anatomy on-line, is intracardiac echocardiography (ICE). It seems that ICE could replace all other techniques used for LA imaging. Also, there may be no need for introducing diagnostic catheters and only ablation catheter and single transseptal puncture will do.

Hypothesis. Simplified ICE-based ablation is faster and with shorter fluoroscopy time than standard ablation without compromising safety and efficacy and with no significant increase in costs.

Aim. To compare procedural data, costs, safety and efficacy of simplified ICE-based ablation versus standard RF ablation for AF.

Methods. This is prospective, controlled trial. Three centers will be included: center 1 where simplified ICE-based procedure is performed and centers 2 and 3 where standard approach is used. Patients with PAF will be allocated to two approaches: (1) standard (n=45) arm undergoing multi-electrode RF ablation in centers 2 and 3 and (2) the simple-ICE group (n=45) undergoing RF ablation in center 1 using ablation catheter and ICE catheter only.

Ablation procedure will be performed using electro-anatomical system according to the CLOSE protocol. In the simple-ICE group PVI is confirmed by lack of LA capture during pacing from or up to 5 mm inside the ablation line. In the standard group both pacing from ablation line and signals from the circular diagnostic electrode will be used to confirm PVI.

A one year follow-up is planned including three visits in cardiology clinics with 4-7 day Holter ECG 3, 6 and 12 months after the procedure.

Assessed outcomes include duration of procedure, duration and dose of radiation, one-year procedural efficacy, peri- and post-procedural complications and cost-efficacy

Conditions

Interventions

PROCEDURE

ICE visualization and map construction

Radio-frequency ablation of atrial fibrillation

Sponsors & Collaborators

  • Centre of Postgraduate Medical Education

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2023-05-24
Completion
2024-05-24

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04923009 on ClinicalTrials.gov