NCT05153486

Brief Summary

This is an open label, randomized parallel control clinical trial evaluating the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

November 29, 2021

Last Update Submit

November 29, 2021

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillationsevere atrial fibrosiscatheter ablationsurgical 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 12 months after enrollment

Secondary Outcomes (4)

  • Postoperative AF recurrence rate

    up to 12 months after enrollment

  • Postoperative AFL/AT rate

    up to 12 months after enrollment

  • Incidence of complications

    up to 12 months after enrollment

  • Changes in the diameter of the left atrium and the left ventricular ejection fraction

    up to 12 months after enrollment

Study Arms (3)

Group A

EXPERIMENTAL

Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

Group B

ACTIVE COMPARATOR

Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

Group C

ACTIVE COMPARATOR

Surgical ablation

Procedure: Surgical ablation

Interventions

Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablationPROCEDURE

Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.

Group A
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusionPROCEDURE

Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.

Group B
Surgical ablationPROCEDURE

Patients receive surgical ablation.

Group C

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 with severe atrial fibrosis;
  • Nonresponse or intolerance to ≥1 antiarrhythmic drug.

You may not qualify if:

  • With uncontrolled congestive heart failure;
  • Having significant valvular disease;
  • 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 (LA) thrombus;
  • Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;
  • \. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mu Qin, M.D.

CONTACT

+8613052320103qinmuae@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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

November 29, 2021

First Posted

December 10, 2021

Study Start

December 1, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

December 10, 2021

Record last verified: 2021-11