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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07594886

Acronym

LAP AF-HF

Enrollment

300

Registered

2026-05-19

Start date

2024-02-12

Completion date

2029-12-31

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALLAP-Triggered Heart Failure Optimization Pathway

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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

\- No additional

Design outcomes

Primary

Measure	Time frame	Description
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio	Up to 36 months.	Three-tier hierarchical composite analyzed by unmatched win ratio. Tier 1: cardiovascular death within 3 years of ablation. Tier 2: heart failure hospitalization within 3 years of ablation. Tier 3: echocardiographic response defined as absolute increase in left ventricular ejection fraction of 10 percentage points or more from baseline to protocol-window follow-up echocardiogram at 3 to 18 months.

Secondary

Measure	Time frame	Description
Guideline Adherence Index	Up to 36 months.	Number of heart failure medication classes prescribed divided by the number of classes for which the patient has a guideline-supported indication and no documented contraindication. Ranges from 0 to 1 with higher values indicating greater adherence.
Guideline Adherence Index Area Under the Curve	Up to 36 months.	Time-weighted cumulative guideline adherence calculated from serial medication assessments at baseline, discharge, and scheduled follow-up intervals. Higher values indicate greater sustained guideline-directed medical therapy implementation over time.
Change in Left Ventricular Ejection Fraction From Baseline	Up to 36 months.	Left ventricular ejection fraction measured by biplane Simpson method on transthoracic echocardiography per American Society of Echocardiography recommendations. Reported as absolute change in percentage points from baseline.
Change in Left Atrial Volume Index From Baseline	Up to 36 months.	Left atrial volume indexed to body surface area measured by biplane area-length method on transthoracic echocardiography per American Society of Echocardiography recommendations. Reported as absolute change in mL/m2 from baseline.
Right Ventricular Function and Right Ventricular-Pulmonary Artery Coupling.	Up to 36 months.	Composite right ventricular assessment including tricuspid annular plane systolic excursion in centimeters, tricuspid annular systolic velocity in centimeters per second, tricuspid regurgitation peak velocity in meters per second, and the ratio of tricuspid annular plane systolic excursion to tricuspid regurgitation peak pressure gradient. Each parameter reported as change from baseline.
Atrial Fibrillation Recurrence and Burden After Blanking Period	Up to 12 month.	Atrial fibrillation recurrence defined as any episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting more than 30 seconds documented beyond a 90-day blanking period. Atrial fibrillation burden defined as percentage of time spent in atrial fibrillation ascertained from cardiac implantable electronic device, implantable loop recorder, or ambulatory monitoring. Both reported as post-blanking outcomes.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlexander A Ivanov, MD

Medical College of Wisconsin

PRINCIPAL_INVESTIGATORMarcie MD Berger