NCT02558699

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Aug 2018Dec 2027

First Submitted

Initial submission to the registry

September 23, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
2.9 years until next milestone

Study Start

First participant enrolled

August 24, 2018

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

9.4 years

First QC Date

September 23, 2015

Last Update Submit

December 28, 2022

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months

    18 months

  • Rate of mortality, incidence of cerebral infarction and hospitalization after procedure

    24 months

Secondary Outcomes (3)

  • Major complication related procedure : Complication of hemorrhagic and embolic

    24 months

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

    24 months

  • Procedure time and Radiofrequency ablation time

    24 months

Study Arms (2)

conventional group

ACTIVE COMPARATOR

Group operating the atrial fibrillation by physician's personal experience, not by virtual simulation.

Procedure: physician's personal experience

3D atrial computer model

EXPERIMENTAL

Group choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape.

Procedure: Virtual rotor mapping

Interventions

physician's personal experiencePROCEDURE

physician's personal experience

conventional group
Virtual rotor mappingPROCEDURE

Virtual rotor mapping

3D atrial computer model

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

  • Choi Y, Lim B, Yang SY, Yang SH, Kwon OS, Kim D, Kim YG, Park JW, Yu HT, Kim TH, Yang PS, Uhm JS, Shim J, Kim SH, Sung JH, Choi JI, Joung B, Lee MH, Kim YH, Oh YS, Pak HN; CUVIA-REGAB Investigators. Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation Targeting Restitution Parameter-Guided Catheter Ablation: CUVIA-REGAB Prospective Randomized Study. Korean Circ J. 2022 Sep;52(9):699-711. doi: 10.4070/kcj.2022.0113. Epub 2022 Jul 11.

    PMID: 35927040DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hui-Nam Pak

CONTACT

82-2-2228-8459hnpak@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 24, 2015

Study Start

August 24, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 3, 2023

Record last verified: 2022-12

Locations

KR(1)