Atrial Fibrillation (AF)LAP AF-HFNCT07594886
Left Atrial Pressure-Guided Heart Failure Optimization During Atrial Fibrillation Ablation (LAP AF-HF)
An observational study of Atrial Fibrillation (AF) and Heart Failure, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure, Catheter Ablation
- What is being tested?
- LAP-Triggered Heart Failure Optimization Pathway
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 31 Dec 2029
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Heart and Vascular Center - Center for Advanced Care - Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: 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
Read the detailed description
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.
- Being tested
- LAP-Triggered Heart Failure Optimization Pathway
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAP-Triggered Heart Failure Optimization PathwayBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: LAP-Triggered Heart Failure Optimization Pathway | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio
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.
Measured: Up to 36 months.
Secondary outcomes (6)
Guideline Adherence Index
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.
Measured: Up to 36 months.
Guideline Adherence Index Area Under the Curve
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.
Measured: Up to 36 months.
Change in Left Ventricular Ejection Fraction From Baseline
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.
Measured: Up to 36 months.
Change in Left Atrial Volume Index From Baseline
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.
Measured: Up to 36 months.
Right Ventricular Function and Right Ventricular-Pulmonary Artery Coupling.
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.
Measured: Up to 36 months.
Atrial Fibrillation Recurrence and Burden After Blanking Period
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.
Measured: Up to 12 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start12 Feb 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcie G. Berger, MD, Medical College of Wisconsin
- Investigators
- Alexander A Ivanov, MD, Principal investigator, Medical College of WisconsinMarcie MD Berger, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594886
- Sponsor's protocol ID
- PRO00047951
- Acronym
- LAP AF-HF
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Left Atrial Pressure-Triggered Pathway for Heart Failure Therapy Optimization at Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT07594886
- Acronym / sponsor ID
- LAP AF-HF / PRO00047951
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAP-Triggered Pathway | – | Behavioral: LAP-Triggered Heart Failure Optimization PathwayPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- No additional exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAP-Triggered Heart Failure Optimization PathwayStructured 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 | Behavioural | LAP-Triggered Pathway |
Primary outcome
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio
Time frame: 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.
6 secondary outcomes
Guideline Adherence Index
Time frame: Up to 36 months.
Guideline Adherence Index Area Under the Curve
Time frame: Up to 36 months.
Change in Left Ventricular Ejection Fraction From Baseline
Time frame: Up to 36 months.
Change in Left Atrial Volume Index From Baseline
Time frame: Up to 36 months.
Right Ventricular Function and Right Ventricular-Pulmonary Artery Coupling.
Time frame: Up to 36 months.
Atrial Fibrillation Recurrence and Burden After Blanking Period
Time frame: Up to 12 month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available upon reasonable request to the corresponding author beginning 24 months after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander A Ivanov, MD principal investigator
Medical College of Wisconsin
Marcie MD Berger principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Heart Failure, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite Clinical-Remodeling Outcome Assessed by Win Ratio (time frame: Up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.