Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF) (LAP AF-HF)
17. mai 2026 oppdatert av: 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
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
300
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Wisconsin
-
Milwaukee, Wisconsin, Forente stater, 53226
- Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio
Tidsramme: 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.
|
Up to 36 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Guideline Adherence Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 36 months.
|
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.
Tidsramme: 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
Tidsramme: Up to 12 month.
|
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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Clinically Significant Hyperkalemia
Tidsramme: Up to 36 months.
|
Serum potassium greater than 5.5 mmol/L at any assessment point.
|
Up to 36 months.
|
|
Acute Kidney Injury per KDIGO Criteria
Tidsramme: 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.
|
|
GDMT Discontinuation Rate
Tidsramme: Up to 36 months.
|
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
Tidsramme: Up to 36 months.
|
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
Tidsramme: Up to 36 months.
|
Death from any cause ascertained from the electronic medical record and cross-verified with the Social Security Death Index.
|
Up to 36 months.
|
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Heart Failure Hospitalization
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Alexander A Ivanov, MD, Medical College of Wisconsin
- Hovedetterforsker: Marcie MD Berger, Medical College of Wisconsin
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. februar 2024
Primær fullføring (Antatt)
31. desember 2029
Studiet fullført (Antatt)
31. desember 2029
Datoer for studieregistrering
Først innsendt
10. mai 2026
Først innsendt som oppfylte QC-kriteriene
17. mai 2026
Først lagt ut (Faktiske)
19. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO00047951
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
IPD-delingstidsramme
Beginning 24 months after publication of the primary manuscript and available for 12 months.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
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Nei
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