Additional Low Voltage Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation

NCT03462628 | Completed DMC

• 1 other identifier: 2015-SR-085
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in older patients with paroxysmal AF: Pulmonary vein isolation alone versus additional low-voltage substrate modification during sinus rhythm

Conditions

Paroxysmal Atrial Fibrillation

Keywords

substrate modification; pulmonary vein isolation; ablation; Paroxysmal Atrial Fibrillation

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 (4)

• Incidence of peri-procedural complications

  1 week after patient enrollment

• complications during the follow-up

  1month to 12 months

• Procedure time

  1 week after patient enrollment

• Fluoroscopy time

  1 week after patient enrollment

Study Arms (2)

Study Group

EXPERIMENTAL

PVI with additional low-voltage substrate modification

Procedure: CPVI plus low-voltage substrate modification

Control Group

ACTIVE COMPARATOR

PVI only

Procedure: CPVI alone

Interventions

CPVI plus low-voltage substrate modification PROCEDURE

CPVI plus low-voltage substrate modification in the left atrium during SR

Also known as: CPVI plus additional low-voltage substrate modification

Study Group

CPVI alone PROCEDURE

circumferential pulmonary vein isolation

Control Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients age is 65-80 years;
• Patients with paroxysmal AF;
• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• First Affiliated Hospital of Wannan Medical College: collaborator
• Second Affiliated Hospital of Nantong University: collaborator
• Zhongda Hospital: collaborator
• The Third Affiliated Hospital of Soochow University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Xuzhou Central Hospital, the Affiliated Xuzhou Hospital of Medical College of Southeast University: collaborator
• Air Force Military Medical University, China: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

Related Publications (2)

• Qi X, Chen H, Yang G, Liu H, Wang Z, Jiang X, Cui C, Cai C, Ju W, Chen M. Unipolar Voltage for Better Characterizing Left Atrium Substrates: Comparing the Predictive Efficacy for Recurrence Post Atrial Fibrillation Ablation in a Post Hoc Analysis of STABLE-SR-III Trial. J Cardiovasc Electrophysiol. 2025 Jan;36(1):149-156. doi: 10.1111/jce.16490. Epub 2024 Nov 7.

  PMID: 39511789 DERIVED

• Chen H, Li C, Han B, Xiao F, Yi F, Wei Y, Jiang C, Zou C, Shi L, Ma W, Wang W, Wang Y, Du H, Chen L, Chen M; STABLE-SR-III Investigators. Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial. JAMA Cardiol. 2023 Aug 1;8(8):765-772. doi: 10.1001/jamacardio.2023.1749.

  PMID: 37378966 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Minglong Chen

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 12, 2018
• Study Start: April 24, 2018
• Primary Completion: August 3, 2020
• Study Completion: August 17, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-04

Locations

CN (1)