Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF) (LAP AF-HF)
17 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
300
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio
Délai: 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.
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Up to 36 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Guideline Adherence Index
Délai: 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.
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Up to 36 months.
|
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Guideline Adherence Index Area Under the Curve
Délai: 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.
|
Up to 36 months.
|
|
Change in Left Ventricular Ejection Fraction From Baseline
Délai: 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
Délai: 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.
Délai: 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.
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Up to 36 months.
|
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Atrial Fibrillation Recurrence and Burden After Blanking Period
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Clinically Significant Hyperkalemia
Délai: Up to 36 months.
|
Serum potassium greater than 5.5 mmol/L at any assessment point.
|
Up to 36 months.
|
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Acute Kidney Injury per KDIGO Criteria
Délai: Up to 36 months.
|
Acute kidney injury defined by Kidney Disease Improving Global Outcomes criteria following guideline-directed medical therapy initiation.
|
Up to 36 months.
|
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GDMT Discontinuation Rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Alexander A Ivanov, MD, Medical College of Wisconsin
- Chercheur principal: Marcie MD Berger, Medical College of Wisconsin
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 février 2024
Achèvement primaire (Estimé)
31 décembre 2029
Achèvement de l'étude (Estimé)
31 décembre 2029
Dates d'inscription aux études
Première soumission
10 mai 2026
Première soumission répondant aux critères de contrôle qualité
17 mai 2026
Première publication (Réel)
19 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PRO00047951
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
Délai de partage IPD
Beginning 24 months after publication of the primary manuscript and available for 12 months.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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