Atrial FibrillationNCT07254455
CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction)
A study testing Catheter ablation in people with Atrial Fibrillation and Heart Failure With Preserved Ejection Fraction, run by Tulane University.
Trial summary
The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction/Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF) reflects the scarcity of randomized trials on different treatment modalities. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2031
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at screening visit.
- Clinical signs and symptoms of HF (26).
- Left ventricular ejection fraction (LVEF) >40% within the past 12 months (most recent LVEF measurement)
- Elevated NT-proBNP levels during screening or within 12 months prior to screening (most recent value; blood test):
- For patients in normal sinus rhythm (NSR) at the time of blood sampling: NT proBNP ≥300 pg/mL
- For patients in AF at the time of blood sampling: NT-proBNP ≥600 pg/mL
Show all 15Show fewer
- Echocardiographic evidence of HFmrEF/HFpEF, with at least one of the following during screening or within the 12 months prior to screening:
- Left atrial volume index (LAVI) ≥34 mL/m2 for patients in NSR, or LAVI ≥40 mL/m2 for patients in AF.
- Tricuspid regurgitation (TR) peak velocity >2.8 m/s.
- Mitral E/e' ratio at rest ≥9.
- Left ventricular mass index (LVMI) ≥115 g/m2 for men and ≥95 g/m2 for women.
- Septal thickness or posterior wall thickness ≥1.1 cm.
- Patients previously diagnosed with persistent AF since ≤4 months prior to screening with an indication for anticoagulation, OR Patients previously diagnosed with paroxysmal AF since ≤4 months prior to screening with an already known AF burden of ≥1% and/or an AF episode of ≥24 hours, with an indication for anticoagulation OR Patients with paroxysmal AF without known AF burden (diagnosed since ≤4 months prior to screening) or no previously diagnosed AF who are subsequently diagnosed with AF after receiving a single-lead electrocardiography (ECG) patch for 30 days. These patients should have an AF burden of ≥1% and/or an AF episode of ≥24 hours on the ECG patch (more details down below in section 8.1.1) and an indication for anticoagulation.
- Stable optimal medical therapy for HFmrEF/HFpEF for at least 4 weeks (diuretics \& SGLT2 inhibitors unless contraindicated; angiotensin receptor-neprilysin inhibitors \& mineralocorticoid receptor antagonists as deemed appropriate by the treating physician; Amiodarone and Beta-blockers are not considered for defining heart failure therapy).
- Signed written informed consent obtained from the participant or participant's legal representative and ability for participant to comply with the requirements of the study.
Who cannot join
- Participants will be excluded from the study for any of the following reasons:
- Previous catheter ablation for AF.
- Known infiltrative cardiomyopathy, hypertrophic cardiomyopathy and amyloidosis.
- Documented left atrial diameter >6cm.
- Any contraindication for chronic anticoagulation therapy or heparin, including hypersensitivity to any of the components.
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.
Show all 18Show fewer
- Planned cardiovascular intervention during the follow-up period.
- Patients with severe valvular disease
- Life expectancy ≤12 months.
- Untreated hypothyroidism or hyperthyroidism (blood test).
- Requirement for dialysis due to end-stage chronic kidney disease.
- Mental or physical inability to participate in the study.
- Women currently pregnant (blood test) or breastfeeding or not using reliable contraceptive measures during fertility age.
- Enrollment in another investigational drug or device study within the last 30 days before registration.
- Medical or psychological conditions that would not permit the participant to complete the study or sign informed consent.
- Known alcohol or drug abuse.
- Presence of a condition, abnormality or disease that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.
- Legal incapacity or limited legal capacity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Left Ventricular Ejection Fraction - A Prospective, Randomized, Multi-national Study Using Two Systems for Rhythm Monitoring
The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction/Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF/HFpEF and AF.
The main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF/HFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF/HFpEF.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) is highly prevalent and often coexists with atrial fibrillation (AF), but the optimal management strategy for AF in this population remains unclear. The CASTLE-HFpEF (CASTLE-AF II) trial is a prospective, randomized, multicenter study designed to evaluate whether catheter ablation of AF improves clinical outcomes compared with optimized medical therapy in patients with HFpEF.
Approximately 4,000 patients with HFpEF will undergo AF screening using an insertable cardiac monitor. Of these, 980 patients with newly diagnosed AF or AF detected during screening and with an AF burden > 1% will be randomized 1:1 to catheter ablation or guideline-directed medical therapy. All randomized patients will be followed for three years and monitored continuously for AF burden.
The primary endpoint is a hierarchical composite including all-cause mortality, stroke or transient ischemic attack, hospitalization for worsening heart failure, and a clinically meaningful reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 12 months. Secondary endpoints include total heart failure events, patient-reported quality-of-life outcomes, AF burden and rhythm control metrics, and echocardiographic measures of cardiac structure and function.
This study seeks to determine whether AF ablation improves clinical outcomes and quality of life in patients with HFpEF and AF, and to define the role of rhythm control strategies in this population.
- Being tested
- Catheter ablation
- Keywords
- A-fib, HFpEF, HFmrEF, AF, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
A catheter ablation (CA) is a minimally invasive medical procedure for treatment of cardiac arrhythmias. Rhythm control of AF is attempted by pulmonary vein isolation (PVI) and posterior wall isolation (PWI). During the procedure, a catheter is guided to the heart through a blood vessel, which is either the femoral vein or a central vein, in order to ablate abnormal conductive heart tissue that causes the arrhythmias. Ablation is achieved either by thermal (cauterization by radiofrequency (RF) ablation / freezing by cryoballoon) or non-thermal mechanisms (primarily irreversible electroporation (IRE) through pulsed field ablation (PFA)). In case of successful ablation, a normal heart rhythm (sinus rhythm) can be restored.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical therapy for heart failure with preserved ejection fraction arm | No intervention | Participants randomized to receive medical treatment will be treated according to locally applicable guidelines for standard of care. The choice of the specific pharmacological treatment will be left to the discretion of the treating physician whether it is a rate or rhythm control based on the clinical picture, but maintenance of sinus rhythm through anti arrhythmic drugs (AADs) in this study arm will be encouraged. Electrical cardioversion using a defibrillator is allowed in this study arm. Medical therapy for HFmrEF/HFpEF will be continued following standard of care. |
| Catheter ablation arm | Experimental | Participants assigned to CA will undergo the procedure as soon as possible after baseline evaluation (within 5 weeks), following the Heart Rhythm Society (HRS) consensus statement using pulsed field ablation (PFA). The main aim of the procedure is to achieve isolation of all four pulmonary veins (PVs).
In participants with paroxysmal AF, only pulmonary vein isolation (PVI) will be performed. In participants with persistent AF, posterior wall isolation (PWI) in addition to PVI will be applied.
Medical therapy for HFmrEF/HFpEF will be continued following standard of care. The physician performing the CA must have performed at least 50 prior AF ablation procedures, comprising PVI and PVI +, with the same approach. Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of all-cause mortality, stroke or transient ischemic attack (TIA), and hospitalizations for worsening HF and clinically relevant decrease of NT proBNP (after 12 months)
Hierarchical composite endpoint of the hard outcomes all-cause mortality, stroke or TIA, and hospitalizations for worsening HF (all after 36 months), and clinically relevant decrease of NT proBNP (after 12 months), analyzed using the Win Ratio method for each AF treatment arm (PFA-based CA versus conventional therapy). The Win Ratio is a statistical method designed to analyze composite outcomes with hierarchical clinical priorities, such as death, hospitalization, and functional status.
Each patient in the treatment group is then compared to each patient in the control group, forming all possible unmatched pairs. Within each pair, the patient who experiences the more favorable outcome at the highest priority level is declared the "winner." The Win Ratio is calculated as the total number of wins in the treatment group divided by the number of wins in the control group, providing a clinically intuitive summary of net benefit.
Measured: Baseline, 12 Months, 36 months
Secondary outcomes (5)
Combined hard outcomes (all-cause mortality, stroke or TIA, hospitalizations for worsening HF; time to first event)
The combined hard outcome is defined as the time to the first occurrence of any of the three specified components, and will be analyzed using Kaplan-Meier survival curves and the log-rank test to compare event-free survival between groups.
Measured: 36 months
Total HF-related events (hospitalization for worsening HF and outpatient worsening HF events)
The investigators will count the total HF-related events (hospitalization for worsening HF and outpatient worsening HF events) until the end of study. It will be tested via Poisson regression or negative binomial regression, according to the data distribution. Which model to use will be determined from the likelihood ratio test.
To analyze how often the HF-related events happen. Depending on how the data looks, the investigators will choose between two models - one called Poisson regression and the other called negative binomial regression. To decide which model fits the data better, the investigators will use a statistical method called a "likelihood ratio test," which compares the two models and tells the investigators which one works best for the data.
Measured: 36 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Kansas City Cardiomyopathy Questionnaire (KCCQ) score will be tested by t-test or the Wilcoxon test, according to normal distribution or not determined by the Wil-Shapiro test. KCCQ is a validated, patient-reported outcome measure designed to assess health status in individuals with heart failure. It evaluates multiple domains, including physical limitation, symptom frequency and severity, social function, self-efficacy, and quality of life. Scores range from 0 to 100, with higher scores indicating better health status. The KCCQ is sensitive to clinical changes and is widely used in both clinical trials and practice to measure the impact of heart failure treatments from the patient's perspective. A change of 5-10 points is generally considered clinically meaningful.
Measured: Baseline, 3 Months, 6 months, 12 months, 24 months, 36 months
All-cause mortality (time to event)
All-cause mortality will be tested via Kaplan-Meier curve and Log-rank test. The investigators will measure the survival rate based on the time to event.
Measured: 36 Months
Stroke or TIA (time to event)
Stroke or TIA (time to event): tested via Kaplan-Meier curve and Log-rank test. The investigators will measure the first event a stroke or TIA has happened based on the time to event.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Nassir Marrouche, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254455
- Sponsor's protocol ID
- 26-0025
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Left Ventricular Ejection Fraction - A Prospective, Randomized, Multi-national Study Using Two Systems for Rhythm Monitoring
- ClinicalTrials.gov ID
- NCT07254455
- Acronym / sponsor ID
- 26-0025
- Keywords
- A-fib, HFpEF, HFmrEF, AF, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Johnson & Johnson
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 28 Nov 2025 (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.
The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction/Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF/HFpEF and AF.
The main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF/HFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF/HFpEF.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) is highly prevalent and often coexists with atrial fibrillation (AF), but the optimal management strategy for AF in this population remains unclear. The CASTLE-HFpEF (CASTLE-AF II) trial is a prospective, randomized, multicenter study designed to evaluate whether catheter ablation of AF improves clinical outcomes compared with optimized medical therapy in patients with HFpEF.
Approximately 4,000 patients with HFpEF will undergo AF screening using an insertable cardiac monitor. Of these, 980 patients with newly diagnosed AF or AF detected during screening and with an AF burden > 1% will be randomized 1:1 to catheter ablation or guideline-directed medical therapy. All randomized patients will be followed for three years and monitored continuously for AF burden.
The primary endpoint is a hierarchical composite including all-cause mortality, stroke or transient ischemic attack, hospitalization for worsening heart failure, and a clinically meaningful reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 12 months. Secondary endpoints include total heart failure events, patient-reported quality-of-life outcomes, AF burden and rhythm control metrics, and echocardiographic measures of cardiac structure and function.
This study seeks to determine whether AF ablation improves clinical outcomes and quality of life in patients with HFpEF and AF, and to define the role of rhythm control strategies in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard medical therapy for heart failure with preserved ejection fraction arm | No intervention | –Participants randomized to receive medical treatment will be treated according to locally applicable guidelines for standard of care. The choice of the specific pharmacological treatment will be left to the discretion of the treating physician whether it is a rate or rhythm control based on the clinical picture, but maintenance of sinus rhythm through anti arrhythmic drugs (AADs) in this study arm will be encouraged. Electrical cardioversion using a defibrillator is allowed in this study arm. Medical therapy for HFmrEF/HFpEF will be continued following standard of care. |
| Catheter ablation arm | Experimental | Procedure: Catheter ablationParticipants assigned to CA will undergo the procedure as soon as possible after baseline evaluation (within 5 weeks), following the Heart Rhythm Society (HRS) consensus statement using pulsed field ablation (PFA). The main aim of the procedure is to achieve isolation of all four pulmonary veins (PVs). In participants with paroxysmal AF, only pulmonary vein isolation (PVI) will be performed. In participants with persistent AF, posterior wall isolation (PWI) in addition to PVI will be applied. Medical therapy for HFmrEF/HFpEF will be continued following standard of care. The physician performing the CA must have performed at least 50 prior AF ablation procedures, comprising PVI and PVI +, with the same approach. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥18 years of age at screening visit.
- Clinical signs and symptoms of HF (26).
- Left ventricular ejection fraction (LVEF) >40% within the past 12 months (most recent LVEF measurement)
- Elevated NT-proBNP levels during screening or within 12 months prior to screening (most recent value; blood test):
- Echocardiographic evidence of HFmrEF/HFpEF, with at least one of the following during screening or within the 12 months prior to screening:
Key exclusion criteria (18 listed)
- Participants will be excluded from the study for any of the following reasons:
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 |
|---|---|---|
| Catheter ablationA catheter ablation (CA) is a minimally invasive medical procedure for treatment of cardiac arrhythmias. Rhythm control of AF is attempted by pulmonary vein isolation (PVI) and posterior wall isolation (PWI). During the procedure, a catheter is guided to the heart through a blood vessel, which is either the femoral vein or a central vein, in order to ablate abnormal conductive heart tissue that causes the arrhythmias. Ablation is achieved either by thermal (cauterization by radiofrequency (RF) ablation / freezing by cryoballoon) or non-thermal mechanisms (primarily irreversible electroporation (IRE) through pulsed field ablation (PFA)). In case of successful ablation, a normal heart rhythm (sinus rhythm) can be restored. | Procedure or surgery | Catheter ablation arm |
Primary outcome
Composite endpoint of all-cause mortality, stroke or transient ischemic attack (TIA), and hospitalizations for worsening HF and clinically relevant decrease of NT proBNP (after 12 months)
Time frame: Baseline, 12 Months, 36 months
Hierarchical composite endpoint of the hard outcomes all-cause mortality, stroke or TIA, and hospitalizations for worsening HF (all after 36 months), and clinically relevant decrease of NT proBNP (after 12 months), analyzed using the Win Ratio method for each AF treatment arm (PFA-based CA versus conventional therapy). The Win Ratio is a statistical method designed to analyze composite outcomes with hierarchical clinical priorities, such as death, hospitalization, and functional status. Each patient in the treatment group is then compared to each patient in the control group, forming all possible unmatched pairs. Within each pair, the patient who experiences the more favorable outcome at the highest priority level is declared the "winner." The Win Ratio is calculated as the total number of wins in the treatment group divided by the number of wins in the control group, providing a clinically intuitive summary of net benefit.
5 secondary outcomes
Combined hard outcomes (all-cause mortality, stroke or TIA, hospitalizations for worsening HF; time to first event)
Time frame: 36 months
Total HF-related events (hospitalization for worsening HF and outpatient worsening HF events)
Time frame: 36 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Baseline, 3 Months, 6 months, 12 months, 24 months, 36 months
All-cause mortality (time to event)
Time frame: 36 Months
Stroke or TIA (time to event)
Time frame: 36 Months
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 1 Oct 2026.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Nassir Marrouche, MD principal investigator
Tulane University
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation in people with Atrial Fibrillation and Heart Failure With Preserved Ejection Fraction, run by Tulane University.
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 15 inclusion and 18 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Kunal Sameer, MD, MHA (504-988-3062, ksameer@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of all-cause mortality, stroke or transient ischemic attack (TIA), and hospitalizations for worsening HF and clinically relevant decrease of NT proBNP (after 12 months) (time frame: Baseline, 12 Months, 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 1 Oct 2026.