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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
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

TAP-CHF Trial 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.Check my eligibility
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.See study design
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.

TAP-CHF Trial 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 heart failure with preserved ejection fraction and irregular heartbeats.
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I have atrial fibrillation and have been on diuretics for heart failure symptoms for over 30 days.
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I am a candidate for a procedure to correct heart rhythm and may need medication for heart rhythm control.
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I have been on heart failure medication for over 30 days.
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I am eligible for long-term blood thinner therapy for atrial fibrillation.

TAP-CHF Trial 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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Composite of Heart failure hospitalizations and/or Cardiovascular mortality
Secondary outcome measures
All cause Mortality
Cardiovascular Hospitalization
MACE events

TAP-CHF Trial Design

4Treatment groups
Active Control
Group I: 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 II: 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 III: 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
Group IV: 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.

Find a Location

Who is running the clinical trial?

Electrophysiology Research FoundationLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
5 Patients Enrolled for Atrial Fibrillation
Sanjeev Saksena, MDStudy ChairElectrophysiology Research Foundation
Andrea Natale, MDStudy DirectorElectrophysiology Research Foundation
35 Previous Clinical Trials
7,858 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
7,079 Patients Enrolled for Atrial Fibrillation

Media Library

Catheter ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04160000 — Phase 4
Atrial Fibrillation Research Study Groups: Phase 1 Antiarrhythmic drug therapy, Phase 2 Guided Heart Failure Therapy, Phase 2 Empiric Heart Failure Therapy, Phase 1 Catheter Ablation
Atrial Fibrillation Clinical Trial 2023: Catheter ablation Highlights & Side Effects. Trial Name: NCT04160000 — Phase 4
Catheter ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04160000 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research include senior citizens aged 75 and above?

"This clinical trial seeks participants aged 18-75 for enrollment."

Answered by AI

What is the geographical spread of this research endeavor?

"This trial is operational at 7 sites, including the Kansas City Heart Rhythm Institute in Overland Park, South Denver Cardiology in Littleton and Arizona Heart Rhythm Center in Phoenix. Four other locations are also taking part."

Answered by AI

What eligibility criteria must be met to take part in this research?

"This medical experiment is currently sourcing 360 individuals with heart failure and diastolic between 18-75. In order to be accepted, the patient must meet all three aforementioned criteria."

Answered by AI

What risk factors should be considered before undertaking Phase 2 Empiric Heart Failure Therapy?

"We have rated Phase 2 Empiric Heart failure Therapy as a level 3 on our safety scale since it has been approved for use in the fourth phase of clinical trials."

Answered by AI

Does this clinical research currently accommodate participants?

"Confirmed. Clinicaltrials.gov indicates that this medical study is actively seeking participants, with the first posting on July 26th 2020 and subsequent updates being made as recently as October 18th 2022. This trial requires 360 individuals to be recruited from 7 separate research sites."

Answered by AI

How many individuals have the opportunity to participate in this trial?

"Absolutely. Research available on clinicaltrials.gov proposes that this trial is currently recruiting volunteers, with the initial posting being made on July 26th 2020 and the most recent update occurring October 18th 2022. 360 patients are required to participate at 7 medical centres across the US."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Hospital of the University of Pennsylvania
Recent research and studies
~0 spots leftby Mar 2024