Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF) (LAP AF-HF)
17 de maio de 2026 atualizado 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
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Estimado)
300
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Guideline Adherence Index
Prazo: 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
Prazo: 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
Prazo: Up to 36 months.
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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
Prazo: 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.
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Clinically Significant Hyperkalemia
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Alexander A Ivanov, MD, Medical College of Wisconsin
- Investigador principal: Marcie MD Berger, Medical College of Wisconsin
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de fevereiro de 2024
Conclusão Primária (Estimado)
31 de dezembro de 2029
Conclusão do estudo (Estimado)
31 de dezembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
10 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de maio de 2026
Primeira postagem (Real)
19 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PRO00047951
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
Prazo de Compartilhamento de IPD
Beginning 24 months after publication of the primary manuscript and available for 12 months.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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