NCT03448562

Brief Summary

The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone.

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
300

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2018

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

December 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2.5 years

First QC Date

December 27, 2017

Last Update Submit

February 7, 2020

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationPulmonary Vein IsolationCatheter AblationSubstrate Modification

Outcome Measures

Primary Outcomes (1)

  • Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs)

    Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts \> 30 seconds.

    at least 12 months follow up

Secondary Outcomes (5)

  • Incidence of peri-procedural complications

    1 week after patient enrollment

  • Procedure time

    1 week after patient enrollment

  • Fluoroscopy time

    1 week after patient enrollment

  • Occurrence of the conversion from AF to AT

    at least 12 months follow up

  • Relationship between acute termination of AF and long term outcome

    at least 12 months follow up

Study Arms (2)

Study Group

EXPERIMENTAL

CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR)

Procedure: CPVIProcedure: STABLE-SR

Control Group

ACTIVE COMPARATOR

CPVI alone

Procedure: CPVI

Interventions

CPVIPROCEDURE

ablate around the pulmonary vein orifice

Control GroupStudy Group
STABLE-SRPROCEDURE

homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm

Study Group

Eligibility Criteria

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

You may qualify if:

  • Patients age is 18-80 years;
  • Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days;
  • Patients can sign the written informed consent for the study;
  • Patients can endure the required follow-up.

You may not qualify if:

  • Patients with previous radiofrequency ablation;
  • Patients with PLT count less than 80×109/L, or with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor;
  • Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view);
  • Patients with thromboemboli in LA (TEE or MSCT);
  • Patients with severe structural cardiac disease (medium or severe mitral regurgitation, DCM, HCM, or other severe valvular heart diseases);
  • Patients with abnormal thyroid function;
  • Patients with severe liver or renal dysfunction (AST or ALT \> 3-fold of upper limit value; the SCr \> 3.5 mg/dl or Ccr \< 30 ml/min);
  • Previous surgery history in last 3 months;
  • Patients with life expectancy \< 12 months; and
  • Patients who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (2)

  • Zhang H, Chen N, Bian Q, Yuan M, Yang G, Shen Y, Chen H, Ju W, Li M, Gu K, Wu N, Liu H, Chen M. Persistent atrial fibrillation with left atrial low-voltage area: who benefit from additional modification? Europace. 2025 May 7;27(5):euaf095. doi: 10.1093/europace/euaf095.

    PMID: 40327545DERIVED

  • Yang G, Zheng L, Jiang C, Fan J, Liu X, Zhan X, Li J, Wang L, Yang H, Zhu W, Du H, Ma G, Ma W, Kojodjojo P, Chen M; STABLE-SR-II Investigators. Circumferential Pulmonary Vein Isolation Plus Low-Voltage Area Modification in Persistent Atrial Fibrillation: The STABLE-SR-II Trial. JACC Clin Electrophysiol. 2022 Jul;8(7):882-891. doi: 10.1016/j.jacep.2022.03.012. Epub 2022 Apr 27.

    PMID: 35863814DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gang Yang, MD

CONTACT

86-2568303115yanggang201301@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of the Department of Cardiology

Study Record Dates

First Submitted

December 27, 2017

First Posted

February 28, 2018

Study Start

April 1, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

CN(1)