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Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

NCT05081310 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-22

No results posted yet for this study

Summary

There is still unresolved question whether isolation of superior vena cava (SVC) in conjunction to conventional pulmonary vein isolation (PVI) improves outcomes in the treatment of paroxysmal atrial fibrillation. The investigators are conducting a randomized study to determine if SVC isolation (in addition to pulmonary vein isolation) with the cryoballoon technology can improve freedom from atrial arrhythmias in one year follow up after the ablation.

Conditions

Interventions

DEVICE

superior vena cava isolation

SVC isolation by the means of cryoballoon

DEVICE

pulmonary vein isolation

conventional pulmonary vein isolation by the means of cryoballoon

Sponsors & Collaborators

  • University of Zagreb

    lead OTHER

Principal Investigators

  • Vedran Velagic, MD, PhD · Clinical Hospital Centre Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-07-30
Completion
2024-07-30

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 NCT05081310 on ClinicalTrials.gov