NCT05454111

Brief Summary

This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

3.3 years

First QC Date

July 5, 2022

Last Update Submit

July 11, 2022

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillationcatheter ablationCARTO-Finder-guided ablationMultiscale entropy-guided ablation

Outcome Measures

Primary Outcomes (1)

  • Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate

    AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration

    up to 24 months after enrollment

Secondary Outcomes (2)

  • Postoperative AF recurrence rate

    up to 24 months after enrollment

  • Postoperative AFL/AT rate

    up to 24 months after enrollment

Other Outcomes (3)

  • Changes in the diameter of the left atrium

    up to 24 months after enrollment

  • Changes in the diameter of the left ventricular ejection fraction

    up to 24 months after enrollment

  • Incidence of complications

    up to 24 months after enrollment

Study Arms (2)

CARTO-Finder-guided ablation plus PVI

ACTIVE COMPARATOR

Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors.

Procedure: CARTO-Finder-guided ablation plus PVI

Multiscale entropy-guided ablation plus PVI

EXPERIMENTAL

Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors.

Procedure: Multiscale entropy-guided ablation plus PVI

Interventions

Multiscale entropy-guided ablation plus PVIPROCEDURE

The multiscale entropy is calculated based on intracardiac electrical signals, higher multiscale entropy value indicates closer to the core of rotors which maintains the persistent atrial fibrillation.

Multiscale entropy-guided ablation plus PVI
CARTO-Finder-guided ablation plus PVIPROCEDURE

CARTO-Finder-guided ablation plus PVI

CARTO-Finder-guided ablation plus PVI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 80 years old
  • Persistent AF
  • Nonresponse or intolerance to ≥1 antiarrhythmic drug

You may not qualify if:

  • With uncontrolled congestive heart failure;
  • Having significant valvular disease;
  • Having moderate-to-severe pulmonary hypertension;
  • With myocardial infarction or stroke within 6 months of screening;
  • With Significant congenital heart disease;
  • Ejection fraction was \<40% measured by echocardiography;
  • Allergic to contrast media;
  • Contraindication to anticoagulation medications;
  • Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
  • Left atrial thrombus;
  • Having any contraindication to right or left sided heart catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xu Liu, M.D.

CONTACT

18017321689heartlx@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, deputy director of cardiology department of Shanghai Chest Hospital

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 12, 2022

Study Start

September 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

CN(1)