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CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications

NCT04122963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-12

No results posted yet for this study

Summary

In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).

Conditions

Interventions

PROCEDURE

High power CLOSE-guided PVI ablation

CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)

PROCEDURE

Standard CLOSE-guided PVI ablation

Standard AF ablation according to the CLOSE-protocol

Sponsors & Collaborators

  • AZ Sint-Jan AV

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2019-09-25
Completion
2020-06-30

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT04122963 on ClinicalTrials.gov