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Catheter Ablation + HF Therapies for Heart Failure and Atrial Fibrillation (TAP-CHF Trial)
TAP-CHF Trial Summary
This trial will study the effects of rhythm control and optimized HF therapies in an AF with HFpEF study population.
TAP-CHF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTAP-CHF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TAP-CHF Trial Design
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Who is running the clinical trial?
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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.I have heart failure with preserved ejection fraction and irregular heartbeats.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.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.My heart condition is due to a potentially reversible cause like inflammation.I have not had a heart attack or severe heart issue in the last month.I am not pregnant, nursing, or if capable of becoming pregnant, I am on effective birth control.I am a premenopausal woman not using or planning to stop birth control during the study.I am over 50, or if female, I am post-menopausal or on continuous birth control.You have had a bad reaction to medications for heart rhythm problems in the past.You are expected to live for less than one year.I am eligible for a procedure to correct my heart rhythm and may need medication for it.I have a heart condition that may require or has required a special pacemaker.I had a heart procedure to improve blood flow within the last 3 months.My kidney function is either very low or very high.I have a blood clot in my heart or my heart's pumping ability is below 40%.I cannot take medication to control my irregular heartbeat.I do not have serious liver, lung, or heart conditions that could interfere with the trial.I have not had a stroke, blood clot, or similar event in the last 3 months.I have not had a major bleeding event or brain bleed in the last 3 months.I am not a candidate for heart or organ transplant, nor have I had recent heart surgery.I need ACE inhibitors or ARBs for my health condition.I have heart failure with normal heart pumping function and irregular heartbeats.I have heart failure with preserved ejection fraction and irregular heartbeats.I have atrial fibrillation and have been on diuretics for heart failure symptoms for over 30 days.Your heart's pumping ability is good, and it is above a certain level when checked using standard imaging methods.You have a recorded history of atrial fibrillation shown on an ECG.I am a candidate for a procedure to correct heart rhythm and may need medication for heart rhythm control.I have been on heart failure medication for over 30 days.I am eligible for long-term blood thinner therapy for atrial fibrillation.I have heart failure with normal pumping function and irregular heartbeats.
- Group 1: Phase 1 Antiarrhythmic drug therapy
- Group 2: Phase 2 Guided Heart Failure Therapy
- Group 3: Phase 2 Empiric Heart Failure Therapy
- Group 4: Phase 1 Catheter Ablation
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the research include senior citizens aged 75 and above?
"This clinical trial seeks participants aged 18-75 for enrollment."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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