CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF

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.

Conditions

• Atrial Fibrillation

Interventions

PROCEDURE

CPVI

ablate around the pulmonary vein orifice

PROCEDURE

STABLE-SR

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• First Affiliated Hospital of Wannan Medical College

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• General Hospital of Shenyang Military Region

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Southlake Regional Health Centre

  collaborator OTHER

• German Heart Institute

  collaborator OTHER

• Asklepios Kliniken Hamburg GmbH

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• National Heart Centre Singapore

  collaborator OTHER

• Semmelweis University Heart and Vascular Center

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-01

Primary Completion

2020-09-30

Completion

2020-09-30

Countries

• China

Study Locations