Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF) (LAP AF-HF)
17 de mayo de 2026 actualizado por: Marcie G. Berger, MD, Medical College of Wisconsin
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
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
300
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
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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
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio
Periodo de tiempo: Up to 36 months.
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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.
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Up to 36 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Guideline Adherence Index
Periodo de tiempo: Up to 36 months.
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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.
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Up to 36 months.
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Guideline Adherence Index Area Under the Curve
Periodo de tiempo: Up to 36 months.
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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.
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Up to 36 months.
|
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Change in Left Ventricular Ejection Fraction From Baseline
Periodo de tiempo: 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.
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Up to 36 months.
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Change in Left Atrial Volume Index From Baseline
Periodo de tiempo: Up to 36 months.
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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.
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Up to 36 months.
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Right Ventricular Function and Right Ventricular-Pulmonary Artery Coupling.
Periodo de tiempo: Up to 36 months.
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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.
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Up to 36 months.
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Atrial Fibrillation Recurrence and Burden After Blanking Period
Periodo de tiempo: Up to 12 month.
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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.
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Up to 12 month.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Clinically Significant Hyperkalemia
Periodo de tiempo: Up to 36 months.
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Serum potassium greater than 5.5 mmol/L at any assessment point.
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Up to 36 months.
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Acute Kidney Injury per KDIGO Criteria
Periodo de tiempo: Up to 36 months.
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Acute kidney injury defined by Kidney Disease Improving Global Outcomes criteria following guideline-directed medical therapy initiation.
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Up to 36 months.
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GDMT Discontinuation Rate
Periodo de tiempo: Up to 36 months.
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Proportion of patients newly initiated on sodium-glucose cotransporter 2 inhibitor or mineralocorticoid receptor antagonist who discontinued therapy.
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Up to 36 months.
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Cardiovascular Death
Periodo de tiempo: Up to 36 months.
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Death adjudicated as cardiovascular in origin by two physician investigators blinded to study group assignment with disagreements resolved by a third investigator.
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Up to 36 months.
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All-Cause Mortality
Periodo de tiempo: Up to 36 months.
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Death from any cause ascertained from the electronic medical record and cross-verified with the Social Security Death Index.
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Up to 36 months.
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Heart Failure Hospitalization
Periodo de tiempo: Up to 36 months.
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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.
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Up to 36 months.
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Composite of Heart Failure Hospitalization or All-Cause Death
Periodo de tiempo: Up to 36 months.
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First occurrence of heart failure hospitalization or death from any cause, whichever occurs first.
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Up to 36 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Alexander A Ivanov, MD, Medical College of Wisconsin
- Investigador principal: Marcie MD Berger, Medical College of Wisconsin
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de febrero de 2024
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
10 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2026
Publicado por primera vez (Actual)
19 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRO00047951
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
Marco de tiempo para compartir IPD
Beginning 24 months after publication of the primary manuscript and available for 12 months.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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