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

NCT07594886 | Active Not Recruiting

• 1 other identifier: PRO00047951
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Guideline Adherence Index

  Up to 36 months.

• Guideline Adherence Index Area Under the Curve

  Up to 36 months.

• Change in Left Ventricular Ejection Fraction From Baseline

  Up to 36 months.

• Change in Left Atrial Volume Index From Baseline

  Up to 36 months.

• Right Ventricular Function and Right Ventricular-Pulmonary Artery Coupling.

  Up to 36 months.

Other Outcomes (7)

• Incidence of Clinically Significant Hyperkalemia

  Up to 36 months.

• Acute Kidney Injury per KDIGO Criteria

  Up to 36 months.

• GDMT Discontinuation Rate

  Up to 36 months.

Study Arms (2)

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

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.

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

LAP-Triggered Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander A Ivanov, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Marcie MD Berger

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 19, 2026
• Study Start: February 12, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 24 months after publication of the primary manuscript and available for 12 months.
• 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.

Locations

US (1)