Optimal Ablation Strategies for Persistent AF With HF

NCT07153718 | Active Not Recruiting DMC

• 1 other identifier: EXT- AF&HF
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis. Catheter ablation has been shown to improve outcomes in this population, enhancing ablation success rates in these patients is critical for further reducing morbidity and mortality. We conducted this multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.

Conditions

Heart Failure; Persistent Atrial Fibrillation

Keywords

ablation strategy for persistent atrial fibrillation with heart failure

Outcome Measures

Primary Outcomes (2)

• a composite of cardiovascular mortality, hospitalization or urgent visits

  The primary endpoint was the incidence of a composite of cardiovascular mortality, hospitalization or urgent visits due to worsening heart failure during the follow-up period after a single catheter ablation procedure

  12, 18, 24, 36, 46, 60months

• freedom from any documented AF/AT

  freedom from any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment

  12, 18, 24, 36, 48, 60months

Secondary Outcomes (5)

• AF burden <1%

  12, 24, 36, 48, 60 months after a single procedure

• Improvement in New York Heart Association (NYHA) functional class

  12, 24, 36, 48, 60 months after a single procedure

• Change in 6-minute walk test

  12, 24, 36, 48, 60 months after a single procedure

• Change in N-terminal pro-B type natriuretic peptide (NT-proBNP)

  Month 3,12, 24, 36, 48, 60 after a single procedure

• Incidence of procedure-related complications

  30 days after a single procedure

Study Arms (3)

Anatomical-guided Ablation Group

ACTIVE COMPARATOR

Patients in the ANAT group would receive anatomical-guided ablation after PVI, including linear ablation and Vein of Marshall (VOM) ethanol infusion.

Procedure: Anatomical-guided Ablation

Electrogram-guided Ablation Group

ACTIVE COMPARATOR

Patients in the EGM group received target electrogram ablation after PVI while did not receive anatomical-guided ablation. We defined the target electrograms into 4 types as follows.(1) Spatial-temporal Dispersion Activation (2) Locally Short Cycle Length Activity (3) High-Frequency Potentials (4) Focal Activity

Procedure: Electrogram-guided ablation

Extensive Electrogram-Anatomical Guided Ablation Group

EXPERIMENTAL

Patients in the extensive ablation group (EXT group) would receive EGM-guided ablation firstly. The anatomical-guided ablation would be performed after EGM-guided ablation no matter whether AF terminated during EGM-guided ablation.

Procedure: Extensive electrogram-anatomical guided ablation

Interventions

Electrogram-guided ablation PROCEDURE

pulmonary vein ioslation; target electrograms ablation, including (1) Spatial-temporal Dispersion Activation, (2) Locally Short Cycle Length Activity, (3) High-Frequency Potentials, (4) Focal Activity.

Electrogram-guided Ablation Group

Anatomical-guided Ablation PROCEDURE

pulmonary vein isolation; LA roof, posterior inferior wall and mitral isthmus linear lesion; Vein of Marshall (VOM) ethanol infusion.

Anatomical-guided Ablation Group

Extensive electrogram-anatomical guided ablation PROCEDURE

pulmonary vein isolation; target electrogram ablation; linear ablation

Extensive Electrogram-Anatomical Guided Ablation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Patients aged 18-80 years, with persistent atrial fibrillation (AF) and heart failure (HF), regardless of ejection fraction (EF).
• Diagnosis of Heart Failure:
• Heart Failure with Reduced Ejection Fraction (HFrEF): LVEF ≤ 40%. Heart Failure with Preserved Ejection Fraction (HFpEF): LVEF \> 40%, including HFmrEF (LVEF 41-50%).
• Symptomatic Atrial Fibrillation: Patients with symptomatic persistent AF who have failed or are intolerant to at least one antiarrhythmic drug.
• NYHA Class II-III: Patients with heart failure classified as NYHA class II-III, who are symptomatic despite optimal medical therapy. Informed Consent: Able to provide written informed consent for participation in the study.
• Guideline-Recommended Pharmacologic Therapy: Patients who have received and are currently on guideline-recommended pharmacologic therapy for heart failure, including but not limited to ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists (MRAs).

You may not qualify if:

• Any of the following criteria shall be excluded.
• End-Stage Heart Failure: Patients with heart failure classified as NYHA class IV or with LVEF ≤ 20%.
• Severe Comorbidities:
• Patients with severe pulmonary disease (e.g., COPD, severe restrictive lung disease).
• Severe renal dysfunction (eGFR \< 30 mL/min/1.73m²) or advanced liver disease.
• Active malignancy or other terminal illnesses with a prognosis of less than one year.
• Inability to Tolerate Ablation:
• <!-- -->
• Patients unable to undergo catheter ablation due to anatomical or procedural issues.
• Patients with contraindications to the procedure, including allergy to contrast agents or inability to tolerate anesthesia.
• Left atrial thrombus confirmed by preoperative esophageal ultrasound; 7. Uncontrolled Arrhythmias: Patients with persistent or paroxysmal AF who are unable to maintain sinus rhythm despite optimal medical therapy or require frequent hospitalization for arrhythmia control.
• \. Pregnancy: Pregnant or breastfeeding women. 9. Contraindications to Anticoagulation: 10. Patients who are contraindicated for anticoagulation therapy (e.g., history of major bleeding or bleeding diathesis).
• \. History of Severe Valve Disease: Patients with a history of severe valve disease and/or prosthetic valve replacement.
• \. Recent Myocardial Infarction or Stroke: Patients who have had a myocardial infarction or stroke within the past 3 months.
• \. Contrast Agent Allergy: Patients with a known allergy to contrast agents. 14. Contraindications for Cardiac Catheterization: Any contraindications for cardiac catheterization, including inability to safely perform the procedure.

Sponsors & Collaborators

• Xu Liu: lead

Study Sites (10)

The PLA Navy Anqing Hospital

Anqing, Anhui, 246000, China

Location

The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430014, China

Location

Changshu Hospital of Traditional Chinese Medicine

Changshu, Jiangsu, 215516, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250000, China

Location

Jinan City People's Hospital

Jinan, Shandong, 271100, China

Location

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272000, China

Location

Yuhuan Second People's Hospital

Yuhuan, Zhejiang, 317600, China

Location

Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital

Shanghai, 200030, China

Location

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)