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Procedure

Catheter Ablation + HF Therapies for Heart Failure and Atrial Fibrillation (TAP-CHF Trial)

Phase 4

Recruiting

Research Sponsored by Electrophysiology Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

b) Hospitalization for HF and/or AF in the past 12 months prior to catheter ablation with documented NT-pro BNP >200pg/ml for patients not in AF or > 600 pg/ml for patients in AF on screening ECG or NYHA class 2, 3 or ambulatory class 4 heart failure documented NT-pro BNP >300pg/ml for patients not in AF or > 900 pg/ml for patients in AF on screening ECG

Outpatients ≥ 50 years of age, male or post-menopausal female patients; premenopausal female patients who are on and will maintain continuous birth control therapy during the study

Must not have

Patients with HFpEF who were not on any drug therapy for HF or have uncontrolled hypertension defined as systolic BP >180 mm Hg at screening or >150 mm Hg on three or more antihypertensive drugs

Contraindications to anticoagulant therapy or adverse event with prior Warfarin or DOAC therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of death from any cause, assessed up to 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will study the effects of rhythm control and optimized HF therapies in an AF with HFpEF study population.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications from catheter ablation such as bleeding or infection; adverse reactions to antiarrhythmic drugs like dizziness or nausea; risks associated with CardioMems monitor insertion; and typical side effects of empiric heart failure medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am over 50, or if female, I am post-menopausal or on continuous birth control.

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I have heart failure with normal heart pumping function and irregular heartbeats.

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I have been on heart failure medication for over 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My heart condition is due to a potentially reversible cause like inflammation.

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I am not pregnant, nursing, or if capable of becoming pregnant, I am on effective birth control.

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I am a premenopausal woman not using or planning to stop birth control during the study.

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My kidney function is either very low or very high.

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I have a blood clot in my heart or my heart's pumping ability is below 40%.

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I cannot take medication to control my irregular heartbeat.

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I do not have serious liver, lung, or heart conditions that could interfere with the trial.

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I have not had a stroke, blood clot, or similar event in the last 3 months.

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I have not had a major bleeding event or brain bleed in the last 3 months.

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I am not a candidate for heart or organ transplant, nor have I had recent heart surgery.

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I need ACE inhibitors or ARBs for my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of death from any cause, assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of death from any cause, assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause, assessed up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Composite of Heart failure hospitalizations and/or Cardiovascular mortality

Secondary study objectives

All cause Mortality

Cardiovascular Hospitalization

MACE events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Active Control

Group I: Phase 1 Catheter AblationActive Control1 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 therapyActive Control1 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 TherapyActive Control1 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 TherapyActive Control1 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

0 / 17Eligibility criteria met