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NCT07594886 · ClinicalTrials.gov registry record
Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF)
A clinical trial, sponsored by Medical College of Wisconsin.
- Active
- Registry status
- 300
- Enrollment target
NCT07594886: Active study, sponsored by Medical College of Wisconsin.
NCT07594886 is a clinical trial that is active but no longer recruiting, run by Medical College of Wisconsin. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07594886 is active but no longer recruiting, sponsored by Medical College of Wisconsin.
- ACTIVE NOT RECRUITING
- Registry status
- 300 participants
- Enrollment target
Study Summary
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
Primary Outcome
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.
Interventions
- BEHAVIORAL LAP-Triggered Heart Failure Optimization Pathway
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-02-12 |
| Est. Completion | 2029-12-31 |
What the registry record for NCT07594886 still lists
NCT07594886 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which LAP-Triggered Heart Failure Optimization Pathway is the first listed.
NCT07594886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07594886 about?
NCT07594886 is a clinical study titled "Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF)". 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 c...
What is the current status of trial NCT07594886?
This trial is currently active not recruiting. The enrollment target is 300 participants. The study started on 2024-02-12. Estimated completion is 2029-12-31.
What interventions are being tested in trial NCT07594886?
The interventions under investigation include: LAP-Triggered Heart Failure Optimization Pathway (BEHAVIORAL).
Who is sponsoring clinical trial NCT07594886?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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