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

Atrial Fibrillation Clinical Trial

— STABLE-SR_II  

Official title:

Circumferential Pulmonary Vein Isolation Alone Versus. Circumferential Pulmonary Vein Isolation Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm for the Treatment of Non-paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448562
• Other study ID #: 2017-SR-322
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Gang Yang, MD
• Phone: 86-2568303115
• Email: yanggang201301[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder, which affects patients' morbidity and mortality. AF ablation has emerged as a promising treatment strategy, offering the possibility of a durable treatment. Currently, there is no general agreement regarding NPAF ablation strategy. Obviously, pulmonary vein isolation is the corner stone for all types of AF ablation. The consensus is that CPVI alone is insufficient for NPAF ablation. However, the recent clinical trials did not show the additional benefits of other substrate modification strategies. Furthermore, the widely used cryo-ablation dilutes the concept that NPAF needs additional substrate modification to further improve the clinical outcome. It seems that CPVI only as the optimal strategy is more commonly accepted for NPAF patients in most of the centers. Based on the results from our pilot study and STABLE-SR trial, we believe that fibrotic substrate modification beyond CPVI is very promising for NPAF ablation, but its superiority over CPVI alone needs a large scaled randomized trial to prove.

AIM OF THE STUDY: 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. The primary endpoint is 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. The secondary endpoint are incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death; procedure time; fluoroscopy time (including the total fluoroscopy time, during CPVI and after CPVI); the occurrence of the conversion from AF to AT, and its relationship with long-term outcome; the relationship between acute termination of AF and long term outcome.

STUDY DESIGN: This is a randomized, prospective, parallel, single-blind multicenter design. The enrollment target for this investigation is 300 patients. Patients are randomized in a 1:1 fashion into one of the investigation arms: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone. Follow-up for these patients includes visits at 3 m, 6 m, 9 m, 12 m.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• CPVI
ablate around the pulmonary vein orifice
• STABLE-SR
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (18)

Lead Sponsor

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Asklepios Kliniken Hamburg GmbH, First Affiliated Hospital of Wannan Medical College, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital, Sun Yat-Sen University, Fudan University, General Hospital of Shenyang Military Region, German Heart Institute, Guangdong Provincial People's Hospital, National Heart Centre Singapore, National University Hospital, Singapore, Royal Brompton & Harefield NHS Foundation Trust, Semmelweis University Heart and Vascular Center, Southlake Regional Health Centre, The Second Hospital of Hebei Medical University, University of Minnesota, University of Pennsylvania, Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of peri-procedural complications	stroke, PV stenosis, cardiac perforation, esophageal injury and death	1 week after patient enrollment
Secondary	Procedure time	time that the patient spend in the procedure room	1 week after patient enrollment
Secondary	Fluoroscopy time	the total fluoroscopy time, during CPVI and after CPVI	1 week after patient enrollment
Secondary	Occurrence of the conversion from AF to AT	the occurrence of the conversion from AF to AT, and its relationship with long-term outcome	at least 12 months follow up
Secondary	Relationship between acute termination of AF and long term outcome	the relationship between acute termination of AF and long term outcome	at least 12 months follow up