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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Atrial Fibrillation (AF); Catheter Ablation; Guideline Implementation
• Intervention / Treatment: Behavioral: LAP-Triggered Heart Failure Optimization Pathway

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing catheter ablation for atrial fibrillation at Froedtert Hospital, Medical College of Wisconsin, with intraprocedural mean left atrial pressure of 15 mmHg or greater measured immediately after transseptal puncture. The study includes a prospective pathway cohort (2024 onwards) and a historical standard-care cohort (2022-2023) meeting the same procedural and hemodynamic criteria.

Description

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 exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: LAP-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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio	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.	Up to 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Guideline Adherence Index	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.	Up to 36 months.
Guideline Adherence Index Area Under the Curve	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.	Up to 36 months.
Change in Left Ventricular Ejection Fraction From Baseline	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.	Up to 36 months.
Change in Left Atrial Volume Index From Baseline	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.	Up to 36 months.
Right Ventricular Function and Right Ventricular-Pulmonary Artery Coupling.	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.	Up to 36 months.
Atrial Fibrillation Recurrence and Burden After Blanking Period	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.	Up to 12 month.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Clinically Significant Hyperkalemia	Serum potassium greater than 5.5 mmol/L at any assessment point.	Up to 36 months.
Acute Kidney Injury per KDIGO Criteria	Acute kidney injury defined by Kidney Disease Improving Global Outcomes criteria following guideline-directed medical therapy initiation.	Up to 36 months.
GDMT Discontinuation Rate	Proportion of patients newly initiated on sodium-glucose cotransporter 2 inhibitor or mineralocorticoid receptor antagonist who discontinued therapy.	Up to 36 months.
Cardiovascular Death	Death adjudicated as cardiovascular in origin by two physician investigators blinded to study group assignment with disagreements resolved by a third investigator.	Up to 36 months.
All-Cause Mortality	Death from any cause ascertained from the electronic medical record and cross-verified with the Social Security Death Index.	Up to 36 months.
Heart Failure Hospitalization	Admission exceeding 24 hours with a primary discharge diagnosis of heart failure and treatment with intravenous diuretics, vasodilators, or inotropes, in accordance with standardized cardiovascular endpoint definitions.	Up to 36 months.
Composite of Heart Failure Hospitalization or All-Cause Death	First occurrence of heart failure hospitalization or death from any cause, whichever occurs first.	Up to 36 months.

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Alexander A Ivanov, MD, Medical College of Wisconsin; Principal Investigator: Marcie MD Berger, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: PRO00047951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
• IPD Sharing Time Frame: Beginning 24 months after publication of the primary manuscript and available for 12 months.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal directed to irb@mcw.edu. Requestors will be required to sign a data access agreement. Data will be provided in a de-identified format.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No