MedTrace Logo

Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation

NCT06183879 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-05-28

No results posted yet for this study

Summary

The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF).

The main aims of the study are:

* to compare the efficacy of two ablation devices (acute and 1 year success rates)
* to compare the procedural characteristics (procedure duration, fluoroscopy duration, ablation time
* to compare the complication rates

Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon. Standard of care cryoballoon procedure will be performed alongside with standard postprocedural follow-up.

• to compare the complication rates

Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon.

Conditions

Interventions

DEVICE

cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)

Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon

DEVICE

cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)

Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon

Sponsors & Collaborators

  • University of Zagreb

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-01-01
Completion
2026-01-01

Countries

  • Croatia

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 NCT06183879 on ClinicalTrials.gov