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临床试验/NCT07594886
NCT07594886进行中(未招募)不适用

A Left Atrial Pressure-Triggered Pathway for Heart Failure Therapy Optimization at Atrial Fibrillation Ablation

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1

研究概览

简要总结

This study examines whether measuring blood pressure inside the left upper chamber of the heart during a procedure to treat an irregular heartbeat called atrial fibrillation can help identify patients who would benefit from heart failure medications. During atrial fibrillation ablation, a catheter crosses into the left atrium, allowing direct measurement of left atrial pressure. When the pressure is elevated (15 mmHg or higher), it may indicate that the heart is under strain from unrecognized or undertreated heart failure. Patients with elevated left atrial pressure during ablation are referred for heart failure evaluation and medication optimization within 24 hours of the procedure. The study compares outcomes in these patients to a group of patients who had the same elevated pressures but received standard care without a structured heart failure evaluation. The study measures whether the heart failure treatment pathway leads to greater use of recommended heart failure medications, improvements in heart pumping function and heart chamber size, and reduction in irregular heartbeat episodes over the following year

详细描述

Single-center prospective pathway study with historical standard-care controls at the Medical College of Wisconsin/Froedtert Hospital. Consecutive patients undergoing catheter ablation for atrial fibrillation with intraprocedural mean left atrial pressure of 15 mmHg or greater measured at transseptal puncture are enrolled. Prospective Pathway patients (2024-2025) receive heart failure consultation within 24 hours and structured guideline-directed medical therapy optimization. Historical controls (2022-2023) met identical procedural and hemodynamic criteria but received standard post-ablation care. Guideline-directed medical therapy implementation is quantified serially through 180 days using a guideline adherence index. Echocardiographic remodeling is assessed at 3 to 18 months. Atrial fibrillation burden is assessed by clinically directed rhythm monitoring beyond a 90-day blanking period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred and presented for catheter ablation of atrial fibrillation
  • Able to provide written informed consent
  • Intraprocedural mean left atrial pressure 15 mmHg or greater measured immediately after transseptal puncture -- Written informed consent (prospective cohort 2024- onwards) or institutional review board waiver of consent (historical cohort 2022-2023)

排除标准

  • - No additional exclusion criteria

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcie G. Berger, MD

Professor of Medicine

Medical College of Wisconsin

研究点 (1)

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