Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF) (LAP AF-HF)
2026年5月17日 更新者：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
調査の概要
状態
積極的、募集していない
詳細な説明
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.
研究の種類
観察的
入学 (推定)
300
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ、53226
- Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Guideline Adherence Index
時間枠：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.
|
Up to 36 months.
|
|
Guideline Adherence Index Area Under the Curve
時間枠：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
時間枠：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.
|
Up to 36 months.
|
|
Change in Left Atrial Volume Index From Baseline
時間枠：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.
|
Up to 36 months.
|
|
Right Ventricular Function and Right Ventricular-Pulmonary Artery Coupling.
時間枠：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.
|
Up to 36 months.
|
|
Atrial Fibrillation Recurrence and Burden After Blanking Period
時間枠：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.
|
Up to 12 month.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Clinically Significant Hyperkalemia
時間枠：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
時間枠：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
時間枠：Up to 36 months.
|
Proportion of patients newly initiated on sodium-glucose cotransporter 2 inhibitor or mineralocorticoid receptor antagonist who discontinued therapy.
|
Up to 36 months.
|
|
Cardiovascular Death
時間枠：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.
|
Up to 36 months.
|
|
All-Cause Mortality
時間枠：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.
|
|
Heart Failure Hospitalization
時間枠：Up to 36 months.
|
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.
|
Up to 36 months.
|
|
Composite of Heart Failure Hospitalization or All-Cause Death
時間枠：Up to 36 months.
|
First occurrence of heart failure hospitalization or death from any cause, whichever occurs first.
|
Up to 36 months.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Alexander A Ivanov, MD、Medical College of Wisconsin
- 主任研究者：Marcie MD Berger、Medical College of Wisconsin
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年2月12日
一次修了 (推定)
2029年12月31日
研究の完了 (推定)
2029年12月31日
試験登録日
最初に提出
2026年5月10日
QC基準を満たした最初の提出物
2026年5月17日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月17日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
IPD 共有時間枠
Beginning 24 months after publication of the primary manuscript and available for 12 months.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。