Catheter Ablation + HF Therapies for Heart Failure and Atrial Fibrillation

(TAP-CHF Trial)

Recruiting at 10 trial locations

Overseen By Sanjeev Saksena, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Electrophysiology Research Foundation

Must be taking: Heart failure drugs

Must not be taking: ACE inhibitors, ARBs

Disqualifiers: Uncontrolled hypertension, Recent stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for individuals with both heart failure with preserved function and atrial fibrillation (irregular heartbeat). It aims to evaluate the effectiveness of treatments such as catheter ablation, which stops abnormal electrical signals in the heart, and antiarrhythmic drugs, which control heart rhythm. The study will also investigate whether monitoring heart health with a small implant can guide therapy. Individuals who have experienced heart failure symptoms and irregular heartbeats, and who are currently on heart failure medication, might be suitable candidates for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you must be on standard heart failure drug therapy for at least 30 days before joining the study.

What is the safety track record for these treatments?

Research has shown that catheter ablation is a safe and effective treatment for atrial fibrillation (AF) in patients with heart failure. At experienced centers, it reduces symptoms and hospital stays related to AF. The risk of complications is low and has decreased over the past decade, with a reported death rate of just 1.5 per 100 person-years.

Antiarrhythmic drugs also manage AF. Studies indicate these drugs can help control heart rhythms in AF patients, although effectiveness varies among individuals.

The CardioMEMS hemodynamic monitor, approved by the FDA, has reduced hospital visits for heart failure by 62%. It provides real-time data to better manage heart failure symptoms.

Overall, past research has shown that the treatments under study have good safety records. Each has been successfully used in managing heart failure, with low rates of serious complications. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatments in this trial for heart failure and atrial fibrillation because they explore innovative approaches beyond standard care, which typically includes medications like beta-blockers or ACE inhibitors. The catheter ablation treatment is notable for using radiofrequency, cryothermal, or laser energy to isolate pulmonary veins, potentially offering more precise and durable control of atrial fibrillation than medication alone. Additionally, the use of an implantable hemodynamic monitor in guided heart failure therapy represents a cutting-edge method, allowing real-time monitoring and personalized treatment adjustments, which could lead to better management of heart failure symptoms. These advancements provide hope for more effective and tailored treatment strategies for patients.

What evidence suggests that this trial's treatments could be effective for heart failure with preserved ejection fraction and atrial fibrillation?

In this trial, participants with atrial fibrillation and heart failure will join different treatment arms. One arm involves catheter ablation, which previous studies have shown can reduce symptoms and hospital visits, with more than half of the patients becoming symptom-free without needing extra medication. Another arm involves antiarrhythmic drug therapy, where controlling the heart's rhythm has proven more effective than merely controlling the heart rate, reducing hospital visits for heart failure and lowering the risk of death from heart-related issues. Additionally, the trial includes an arm with the CardioMEMS system, which monitors heart function and has helped reduce hospital visits by enabling early treatment. Finally, there is an arm for empiric heart failure therapy, although treatments for heart failure in patients with normal heart function lack strong evidence of effectiveness. Overall, catheter ablation, drug treatments, and the CardioMEMS system show varying levels of effectiveness, while treatments without strong evidence receive less support from research. ^{3 4 6 7 8}

Who Is on the Research Team?

Sanjeev Saksena, MD

Principal Investigator

Electrophysiology Research Foundation

Andrea Natale, MD

Principal Investigator

Electrophysiology Research Foundation

Are You a Good Fit for This Trial?

This trial is for outpatients over 50 with heart failure and preserved cardiac function (HFpEF) who also have atrial fibrillation. They must be on heart failure drugs for at least a month, eligible for catheter ablation, antiarrhythmic drug therapy, and long-term anticoagulation. Excluded are those with reversible cardiomyopathies, recent acute coronary issues or myocardial infarction, contraindications to anticoagulants, life expectancy under a year, uncontrolled hypertension or significant other medical conditions.

Inclusion Criteria

I have heart failure with preserved ejection fraction and irregular heartbeats.

I was hospitalized for heart failure or atrial fibrillation in the last year and have high NT-pro BNP levels.

Your heart has certain measurements that show it may not be working properly.

Exclusion Criteria

I have heart failure with preserved ejection fraction and either am not on heart failure drugs or have very high blood pressure despite treatment.

I cannot take blood thinners due to health risks or bad reactions in the past.

You haven't been following medical instructions or have social issues that make it hard for you to have regular check-ups, or you have had alcohol or drug problems in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants undergo either catheter ablation or antiarrhythmic drug therapy for atrial fibrillation with preserved systolic function

9 months

Multiple visits for procedure and monitoring

Phase 2 Treatment

Participants receive either guided heart failure therapy with hemodynamic monitoring or empiric heart failure therapy

9 months

Multiple visits for monitoring and therapy adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Catheter ablation
• Empiric heart failure drug therapy
• Insertion of CardioMems Hemodynamic monitor
• Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation

Trial Overview The study tests rhythm control therapies like catheter ablation and antiarrhythmic drugs against optimized heart failure treatments in patients with both HFpEF and atrial fibrillation. It uses wireless pulmonary artery monitoring to optimize treatment. The design is a two-phase randomized controlled pilot trial comparing these approaches.

How Is the Trial Designed?

Group I: Phase 1 Catheter Ablation Active Control 1 Intervention

Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They randomly assigned to catheter ablation as one arm. They will undergo a catheter ablation procedure within 14 days of randomization. This procedure will include isolation of all four pulmonary veins in the antrum using catheter delivered radiofrequency current, cryothermal or laser ablation energy with standard FDA approved ablation catheter systems used in atrial fibrillation ablation. Patients will be monitored for a minimum period of 9 months after the catheter ablation intervention.

Group II: Phase 1 Antiarrhythmic drug therapy Active Control 1 Intervention

Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They will be randomly assigned to antiarrhythmic drug therapy for Rate or Rhythm control in this arm. They will undergo drug dose titration within 14 days of randomization. . Patients will be monitored for a minimum period of 9 months after the AAD therapy initiation

Group III: Phase 2 Guided Heart Failure Therapy Active Control 1 Intervention

Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent and completion of Phase 1. They will be randomly assigned to insertion of an implantable hemodynamic monitor in this arm and heart failure therapy guided by wireless hemodynamic monitoring. Patients will be monitored for a minimum period of 9 months after the implantable hemodynamic monitor insertion on guided drug therapy

Group IV: Phase 2 Empiric Heart Failure Therapy Active Control 1 Intervention

Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent and completion of Phase 1. They will be randomly assigned to heart failure management with empirical selection of heart failure therapy. Patients will be monitored for a minimum period of 9 months after the initiation of empirically selected heart failure drug therapy

Catheter ablation is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Approved in United States as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Approved in Canada as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Approved in Japan as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Who Is Running the Clinical Trial?

Electrophysiology Research Foundation

Lead Sponsor

Trials

2

Recruited

370+

Published Research Related to This Trial

Catheter ablation of atrial fibrillation (AF) in patients with heart failure and reduced ejection fraction (HFrEF) significantly improves clinical outcomes compared to pharmacological rhythm control, which shows no added benefit over rate control.

The higher success rates of catheter ablation in restoring and maintaining normal heart rhythm, along with the side effects associated with antiarrhythmic drugs, highlight the need for optimizing ablation techniques for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcome of Pulmonary Vein Isolation Versus Amiodarone Therapy in Patients with Coexistent Persistent AF and Congestive Heart Failure. Faggioni, M., Della Rocca, DG., Mohanty, S., et al.[2020]

A systematic review of five trials involving 994 patients showed that catheter ablation significantly reduces the recurrence of atrial tachyarrhythmias and symptomatic atrial fibrillation compared to anti-arrhythmic drugs, with odds ratios of 0.36 and 0.32 respectively.

Catheter ablation also led to fewer hospitalizations (odds ratio 0.25) without a significant increase in symptomatic bradycardia, indicating it is a more effective first-line treatment for rhythm control in patients with symptomatic atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter Ablation is Superior to Antiarrhythmic Drugs as First-Line Treatment for Atrial Fibrillation: a Systematic Review and Meta-Analysis. Cardoso, R., Justino, GB., Graffunder, FP., et al.[2022]

Recent evidence indicates that the treatment strategy for atrial fibrillation (AF) can significantly affect the survival of patients with heart failure (HF), suggesting that rhythm control may be more beneficial than previously thought.

Catheter ablation of AF in HF patients has been associated with a reduction in HF-related mortality, making it a preferred treatment option over traditional medical therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of atrial fibrillation-A key role in heart failure therapy? Tose Costa Paiva, B., Fischer, TH., Brachmann, J., et al.[2021]

Catheter ablation is a more effective treatment for maintaining sinus rhythm in patients with atrial fibrillation and heart failure compared to traditional antiarrhythmic drug treatments, which do not show superior results.

While some trials indicate that catheter ablation may reduce hospitalization and mortality rates, further studies are necessary to fully understand its benefits and address existing gaps in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trials of Catheter Ablation of Atrial Fibrillation in Congestive Heart Failure: Knowns and Unmet Needs. Terricabras, M., Piccini, JP., Verma, A.[2019]

Both rhythm control and rate control strategies are acceptable for managing atrial fibrillation (AF), with no clear superiority of one over the other, especially in patients with heart failure.

Catheter ablation techniques, such as radiofrequency and cryotherapy, have shown to be more effective in maintaining sinus rhythm and reducing symptoms compared to antiarrhythmic drugs, particularly in younger patients, although their long-term impact on morbidity and mortality remains to be established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac rhythm management of patients with atrial fibrillation]. Tréguer, F.[2021]

In a study involving 411 patients with high-burden atrial fibrillation and heart failure, ablation-based rhythm control showed a trend towards improved clinical outcomes compared to rate control, although it did not reach statistical significance for all-cause mortality or heart failure events.

Patients receiving ablation-based rhythm control experienced significant improvements in left ventricular ejection fraction, walking distance, and quality of life measures, suggesting potential benefits in heart function and patient well-being despite the overall primary outcome not being statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients With Heart Failure and Atrial Fibrillation: Results from the RAFT-AF trial. Parkash, R., Wells, GA., Rouleau, J., et al.[2022]

Catheter ablation has become a promising alternative to traditional antiarrhythmic drugs for rhythm control in patients with atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF), showing superior outcomes in recent clinical trials.

Patients with HFrEF and AF face higher risks of stroke and mortality, and the advancements in catheter ablation technology over the past decade have made it a more effective treatment option compared to pharmacological methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Atrial Fibrillation in Patients with Co-existing Heart Failure and Reduced Ejection Fraction: Time to Revisit the Management Guidelines? Baher, A., Marrouche, NF.[2020]

Catheter ablation is being increasingly considered as a treatment option for patients with atrial fibrillation and heart failure with reduced ejection fraction, as traditional antiarrhythmic drugs often show limited efficacy and higher risks of side effects.

Current evidence suggests that catheter ablation may improve outcomes in these patients, although careful patient selection is crucial for maximizing its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of atrial fibrillation in heart failure with reduced ejection fraction. Malhi, N., Hawkins, NM., Andrade, JG., et al.[2019]

Atrial fibrillation (AF) is the most common arrhythmia, especially in older patients, and typically requires oral anticoagulants and rate-control treatments to manage heart rate and reduce cardiovascular risks.

For patients not adequately controlled with rate-control therapy, rhythm-control treatments such as antiarrhythmic drugs, cardioversion, or catheter ablation are recommended, with safety being a key factor in choosing the appropriate therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atrial fibrillation: current recommendations for diagnosis and treatment]. Kirchhof, P.[2021]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.023055

Comparative Effectiveness of Early Rhythm Control Versus ... The initiation of rhythm control within 6 months of AF diagnosis reduced the risk of hospitalization for heart failure: 6 months (HR, 0.84; 95% ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38727662/

Rhythm vs Rate Control Strategy for Atrial Fibrillation A rhythm control strategy reduced CV death (HR: 0.78; 95% CI: 0.62-0.96), stroke (HR: 0.801; 95% CI: 0.643-0.998), and hospitalization for HF ( ...

3. jacc.org jacc.org/doi/10.1016/j.jacep.2024.03.006

Rhythm vs Rate Control Strategy for Atrial Fibrillation A rhythm control strategy reduced CV death (HR: 0.78; 95% CI: 0.62-0.96), stroke (HR: 0.801; 95% CI: 0.643-0.998), and hospitalization for HF ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0972629224001190

Comparison of rhythm versus rate control of atrial ... We found high certainty evidence that rhythm control decreased all-cause mortality by 36 % (ARD: 50 fewer deaths per 1000) compared to rate control. This result ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa021328

A Comparison of Rate Control and Rhythm Control in ... At the five-year visit, 34.6 percent of the patients were in sinus rhythm, and over 80 percent of those in atrial fibrillation had adequate heart-rate control.

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038511

Association of Rate‐Control and Antiarrhythmic Medication ... Rhythm control versus rate control in patients with atrial fibrillation and heart failure ... Antiarrhythmic Drugs · Nancy M. Allen LaPointe ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3077493/

Rhythm Control Strategies and the Role of Antiarrhythmic ... Rhythm Control Strategies and the Role of Antiarrhythmic Drugs in the Management of Atrial Fibrillation: Focus on Clinical Outcomes. T Jared Bunch ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.060243

Rate Versus Rhythm Control for Atrial Fibrillation ... Antiarrhythmic Drug Therapy for Atrial Fibrillation) evaluated ... Ablation versus drug therapy for atrial fibrillation in heart failure.