Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT07441382
Status
Recruiting
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Conditions

  • Anticoagulants
  • Atrial Appendage
  • Atrial Fibrillation (AF)
  • Catheter Ablation
  • Frailty
  • Hemorrhage
  • Stroke

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • catheter ablation combined with LAAO (Left Atrial Appendage Occlusion) — DEVICE
    1. Ablation: CPVI will be performed using the EnSite X system and HD Grid catheter. Additional linear ablation (e.g., mitral isthmus or roof lines) may be added based on the patient's atrial substrate if sinus rhythm is not restored. LAAO: An LAA closure device (Watchman FLX, LAmbre, or LACbes) will be implanted under TEE or ICE guidance. 2. Antithrombotic Regimen: Days 0-90: Participants receive OAC (NOAC or Warfarin). Day 90 to 12 Months: If imaging confirms no DRT and no residual leak ≥ 5 mm, therapy will be de-escalated (e.g., to aspirin monotherapy) at the investigator's discretion.
  • Atrial Fibrillation Radiofrequency Ablation Only — DRUG
    Atrial Fibrillation Radiofrequency Ablation: Procedures will be performed using the EnSite X 3D mapping system with an HD Grid high-density mapping catheter for atrial modeling, followed by pulmonary vein isolation using any approved ablation catheter. Linear ablation may be added if necessary. Guideline-directed oral anticoagulation (e.g., NOACs or warfarin) will be continued post-procedure.

Study Details

Atrial fibrillation (AF) is the most common arrhythmia, significantly increasing the risk of stroke, heart failure, hospitalization and death in patients. Studies have shown that standardized anticoagulation can effectively reduce the risk of stroke by 64% and the risk of death by 26% in AF patients. Therefore, both European and American guidelines recommend standardized oral anticoagulation (OAC) as an important treatment strategy for stroke prevention in AF patients. However, the use of OAC may also increase the risk of bleeding in patients. Results from large AF anticoagulation randomized trials show that the annual risk of anticoagulation-related bleeding mortality is 2% to 3%. Therefore, according to the guidelines recommendations, assessing the bleeding risk is necessary in patients with anticoagulant indications. Percutaneous left atrial appendage occlusion (LAAO) is a device-based therapy that aims to prevent ischemic stroke in patients with AF. For patients with contraindications to long-term anticoagulation therapy, LAAO can be considered as an alternative strategy to oral anticoagulation (Class II B recommendation) to prevent ischemic stroke and thromboembolism. Multiple studies have shown that LAAO is non-inferior to warfarin and novel oral anticoagulants in stroke prevention for non-valvular AF patients. Age is not only a risk factor for stroke but also an important risk factor for bleeding. In the elderly population, especially those with frailty, the risk factors for both stroke and bleeding are often increased. Currently, there is insufficient evidence to support the use of OAC in frail elderly patients with relative anticoagulant contraindications. Therefore, elderly AF patients may be one of the potential beneficiary groups for LAAO. However, most previous clinical studies on LAAO were based on small sample sizes to analyze their safety and efficacy, and clinical data on the safety and efficacy of LAAO in this high-risk population of elderly AF patients are still limited. To address this, the study aims to conduct a multicenter randomized controlled trial to compare the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients with high bleeding risk, filling the gap in this research area. To address these limitations, this multicenter randomized controlled trial is designed to evaluate the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients at high risk for bleeding. The primary objective of the study is to compare the 12-month incidence and time-to-occurrence of the composite clinical endpoint. This endpoint includes stroke/TIA, systemic embolism, ISTH-defined major bleeding. By establishing these metrics within the first year, the study aims to fill the current void in clinical evidence and provide a standardized treatment strategy for high-risk elderly patients. In addition to the primary endpoints, the study will conduct a comprehensive long-term evaluation extending to 24 months post-procedure to assess the durability of both treatment strategies. Secondary objectives include the assessment of perioperative safety, specifically focusing on serious intraoperative complications and major adverse events occurring within the first seven days after the LAAO procedure. The trial will also measure long-term rhythm control by tracking the rate of freedom from AF recurrence at the one-year and two-year marks. Furthermore, the study seeks to verify the hypothesized superiority of the ablation-plus-LAAO strategy in reducing the specific burden of anticoagulation-related major bleeding and stroke. Beyond clinical safety and efficacy, the trial will analyze the practical aspects of the two interventions, including procedural success rates, operation duration, fluoroscopy time, and the total duration of hospitalization. A critical component of the research involves identifying specific risk factors associated with complications, with a specialized focus on how frailty scores influence procedural tolerance and long-term prognosis. The study will further explore how different types of AF respond to the LAAO strategy and assess the impact of each treatment on non-major bleeding events. Ultimately, the trial aims to determine which strategy offers a superior improvement in the overall quality of life for elderly patients, thereby optimizing future clinical guidelines.

Key Dates

First listed
Mar 2, 2026
Start date
Mar 24, 2026
Status verified
May 2026
Primary completion
May 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: catheter ablation combined with LAAO
    Participants will receive a combined intervention consisting of catheter ablation for rhythm control and percutaneous left atrial appendage occlusion (LAAO) for stroke prevention. These procedures may be performed either during the same operative session (One-Stop) or as separate. This strategy is used as an alternative to long-term oral anticoagulation in elderly patients with a high risk of bleeding.
  • Active Comparator: Atrial Fibrillation Radiofrequency Ablation Only
    Participants will receive standard-of-care treatment consisting of catheter ablation followed by long-term oral anticoagulation (OAC) for stroke prevention. This arm follows current clinical guidelines to evaluate baseline efficacy and safety outcomes compared to the device-based strategy.

Primary Outcome Measure

Incidence of Net Adverse Clinical Events (NACE) at 12 Months [ Time Frame: 12 months post-randomization ]

Central Contacts

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