AzTrials
AzTrials

Heart FailureNCT07153718

Optimal Ablation Strategies for Persistent AF With HF

A study testing Electrogram-guided ablation, Anatomical-guided Ablation and Extensive electrogram-anatomical guided ablation in people with Heart Failure and Persistent Atrial Fibrillation, run by Xu Liu at 10 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Persistent Atrial Fibrillation
What is being tested?
Electrogram-guided ablation, Anatomical-guided Ablation and Extensive electrogram-anatomical guided ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
10 sitesChina
Study dates
1 Jan 2021to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All inclusion criteria must be met to be included in the study.
  • 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).

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • 8. 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).
  • 11. History of Severe Valve Disease: Patients with a history of severe valve disease and/or prosthetic valve replacement.
  • 12. Recent Myocardial Infarction or Stroke: Patients who have had a myocardial infarction or stroke within the past 3 months.
  • 13. 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.
  • 15. Atrial Fibrillation Ablation: Patients who have previously undergone atrial fibrillation ablation.
  • 16. Cardiac Surgery: Patients who have undergone any cardiac surgery within the last 2 months.
  • 17. Life Expectancy: Patients with a life expectancy of less than 1 year.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • The PLA Navy Anqing Hospital

    Anqing, Anhui, 246000

  • Changshu Hospital of Traditional Chinese Medicine

    Changshu, Jiangsu, 215516

  • Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong, 250000

  • Jinan City People's Hospital

    Jinan, Shandong, 271100

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

  • Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital

    Shanghai, 200030

  • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

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

    Wuhan, Hubei, 430014

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • Yuhuan Second People's Hospital

    Yuhuan, Zhejiang, 317600

Other trials in China

About this study

Official title: Optimal Ablation Strategies for Persistent Atrial Fibrillation With Heart Failure - Optimization of Intervention Strategies for Persistent Atrial Fibrillation

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.

Read the detailed description

Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis, with one-year all-cause mortality rates approaching 34% and substantially elevated risks of stroke and rehospitalization. Catheter ablation has been shown to improve outcomes in this population, as evidenced by numerous pivotal studies, such as CASTLE-AF. It is well recognized that the majority of patients with HF and AF exhibit persistent AF; however, the underlying mechanisms responsible for sustaining persistent AF in this population remain to be fully elucidated. Thus, enhancing ablation success rates in these patients is therefore critical for further reducing morbidity and mortality.

Building on prior research, we have identified driver regions as critical determinants in the maintenance of persistent atrial fibrillation. Moreover, our randomized controlled trials have demonstrated that electro-anatomical ablation may represent the optimal strategy for persistent AF. Based on these findings, we conducted a multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.

Being tested
Electrogram-guided ablation, Anatomical-guided Ablation, Extensive electrogram-anatomical guided ablation
Keywords
ablation strategy for persistent atrial fibrillation with heart failure
Medical subject headings
Heart Failure, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrogram-guided ablationProcedure or surgery

    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.

  • Anatomical-guided AblationProcedure or surgery

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

  • Extensive electrogram-anatomical guided ablationProcedure or surgery

    pulmonary vein isolation; target electrogram ablation; linear ablation

Study groups in NCT07153718
Study groupRoleWhat they receive
Anatomical-guided Ablation GroupActive comparatorPatients in the ANAT group would receive anatomical-guided ablation after PVI, including linear ablation and Vein of Marshall (VOM) ethanol infusion.
Receives: Procedure: Anatomical-guided Ablation
Electrogram-guided Ablation GroupActive comparatorPatients 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
Receives: Procedure: Electrogram-guided ablation
Extensive Electrogram-Anatomical Guided Ablation GroupExperimentalPatients 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.
Receives: Procedure: Extensive electrogram-anatomical guided ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (5)

  1. AF burden <1%

    AF burden <1% after a single ablation procedure, as measured by Holter monitoring or device-recorded data (Patients who remained in persistent AF throughout follow-up were assigned AF burden=100%. Both ends of the distribution (burden=0% and burden=100%) were included in statistical analysis.).

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

  2. Improvement in New York Heart Association (NYHA) functional class

    Improvement in New York Heart Association (NYHA) functional class by at least one grade

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

  3. Change in 6-minute walk test

    Change in 6-minute walk test from baseline to Month 3, 12, 24, 36, 48, 60 months after a single procedure

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

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

    Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) from baseline to Month 3,12, 24, 36, 48, 60 after a single procedure

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

  5. Incidence of procedure-related complications

    Incidence of procedure-related complications, including but not limited to: vascular complications (e.g., hematoma, pseudoaneurysm), cardiac tamponade, stroke or transient ischemic attack (TIA), phrenic nerve injury, atrioesophageal fistula, procedure-related death within 30 days.

    Measured: 30 days after a single procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153718
Sponsor's protocol ID
EXT- AF&HF
Status last verified
Aug 2025
First submitted
26 Aug 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) from this study will not be shared publicly due to concerns regarding patient confidentiality and the sensitive nature of medical data. Given the potential risks of identifying participants from detailed clinical information, the data will remain confidential and will not be made available for public sharing. Additionally, the study involves proprietary methodologies and ongoing analyses that are part of the intellectual property of the institution. As such, sharing the IPD at this stage could compromise the integrity of the study's findings and its future applications.

Publications

  • Li K, Wang X, Qin M, Ye P, Han B, Jiang W, Zhang Y, Zheng Q, Ji A, Zhang M, Wang Y, Wu S, Xu K, Xu C, Liu X, Hou X. Optimal Ablation Strategies for Persistent Atrial Fibrillation With Heart Failure: Three-Year Follow-Up of a Prospective Multicenter Randomized Trial. Circ Arrhythm Electrophysiol. 2026 Apr;19(4):e014394. doi: 10.1161/CIRCEP.125.014394. Epub 2026 Mar 31.

    PubMed 41914182

Questions about this trial

What is this clinical trial studying?

A study testing Electrogram-guided ablation, Anatomical-guided Ablation and Extensive electrogram-anatomical guided ablation in people with Heart Failure and Persistent Atrial Fibrillation, run by Xu Liu at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a composite of cardiovascular mortality, hospitalization or urgent visits (time frame: 12, 18, 24, 36, 46, 60months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07153718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in