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NCT Number: NCT02558699

Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation

Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal atrial fibrillation. In order to reduce the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will conduct virtual rotor mapping in the patient specific atrial model. Then, the investigators will compare the clinical outcome of conventional circumferential pulmonary vein isolation and additional rotor ablation guided by virtual rotor mapping.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location status: Recruiting

Location contact

Hui-Nam Pak, M.D., Ph.D.

CONTACT

[email protected]

82-2-2228-8459

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AF patient age 19~80
  • Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

Exclusion criteria

  • AF patients who have severe heart deformations or vascular disease.
  • The patient who have renal disease of eGFR<30mL/min
  • The patients who had been performed catheter ablation of atrial ablation and MAZE.
  • The patients who missed out to recording of 3D CT, echo and electrocardiography.
  • the patient have experienced major hemorrhagic complication
  • The patient have experienced ischemic cerebral infarction more 2 times
  • The patient who have risk of ischemic cerebral infarction (CHA2DS2-VASc Score >5)

Treatment and study plan

physician's personal experience

Procedure

physician's personal experience

Virtual rotor mapping

Procedure

Virtual rotor mapping

Primary outcomes

  1. Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months

    Time frame: 18 months

  2. Rate of mortality, incidence of cerebral infarction and hospitalization after procedure

    Time frame: 24 months

Secondary outcomes

  1. Major complication related procedure : Complication of hemorrhagic and embolic

    Time frame: 24 months

  2. Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure

    Time frame: 24 months

  3. Procedure time and Radiofrequency ablation time

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Nam Pak

CONTACT

[email protected]

82-2-2228-8459

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: CUVIA-AF II

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2015
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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