Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF)

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07594886
Status
Active Not Recruiting

Conditions

  • Atrial Fibrillation (AF)
  • Catheter Ablation
  • Guideline Implementation
  • Heart Failure

Eligibility Criteria

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

Interventions

  • LAP-Triggered Heart Failure Optimization Pathway — BEHAVIORAL
    Structured heart failure consultation within 24 hours of atrial fibrillation ablation triggered by intraprocedural mean left atrial pressure of 15 mmHg or greater. Consultation includes review of cardiac history, volume status assessment, echocardiographic review, and individualized guideline-directed medical therapy recommendations based on left ventricular ejection fraction phenotype. Final prescribing decisions rest with the treating clinical team

Study Details

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

Key Dates

Start date
Feb 12, 2024
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: LAP-Triggered Pathway
    Patients undergoing atrial fibrillation ablation with intraprocedural mean left atrial pressure of 15 mmHg or greater enrolled prospectively (2024-onwards). Referred for heart failure consultation within 24 hours of ablation with structured guideline-directed medical therapy optimization targeting phenotype-appropriate therapy.
  • Arm: Standard of Care Controls
    Historical cohort (2022-2023) of consecutive patients who underwent atrial fibrillation ablation with intraprocedural mean left atrial pressure of 15 mmHg or greater. Received standard post-ablation care without protocolized heart failure consultation or left atrial pressure-triggered medication optimization.

Primary Outcome Measure

Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio [ Time Frame: Up to 36 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Heart and Vascular Center - Center for Advanced Care - Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Milwaukee, WI

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital· Milwaukee, WI

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