ZERO AF Study: Frequently Asked Questions
What exactly is a research study?
Research studies gather information about new drugs, medical devices or new therapies. The goal of a study may be to gain approval of a new drug, medical device or therapy or may help doctors gain additional knowledge about an illness. Research studies frequently involve people who have heart problems, high blood pressure or diabetes and often involve both sick and healthy people.
What is Paroxysmal Atrial Fibrillation?
Atrial Fibrillation (AF or AFIB) is a type of heart arrhythmia (irregular heartbeat) that disrupts the ability of the heart to beat regularly and pump blood efficiently.
It affects approximately 15 million people worldwide and can lead to complications such as stroke or heart failure.
Paroxysmal Atrial Fibrillation is a type of AFIB in which the irregular heartbeat starts up very quickly, stops spontaneously and abruptly returns to the normal rhythm resulting in patients feeling symptomatic.
What is Radiofrequency Cardiac Ablation?
This is a minimally invasive medical procedure used to treat some types of arrhythmias. The procedure uses radiofrequency (electrical) energy to neutralize (ablate) small areas of heart tissue where abnormal heartbeats may cause an arrhythmia to start. It is a safe and widely used procedure, although some arrhythmias are more readily treated with catheter ablation than others. Your doctor is your best resource for information on treatment options for your arrhythmia.
What are the known Risks?
The investigational components and procedures of this study include risks both known and unknown. Your doctor or healthcare provider can further explain these risks to you.
A list of potential risks can be found in the informed consent form you will be asked to review and sign before participating in this study.
What is the time commitment for this study?
As a ZERO AF Study participant, you will be seen for a screening evaluation, an ablation procedure and once discharged from the hospital you will be required to have 4 follow-up visits and 1 phone contact over a 12-month period. It is important that all patients complete the entire study follow-up.
What are the possible benefits of participating in this clinical study?
The ablation treatment may help you feel better, reduce your dyspnea (breathlessness), palpitations, light-headedness, and/or improve your ability to exercise.
Your heart rhythm will be closely monitored through multiple clinic visits; you may learn more about your cardiac rhythm.
Note: It is possible that you will receive no benefit from the treatment, or that any benefit you experience may be temporary.
Why should I consider participation in this study?
Your participation in this study may help future patients with atrial fibrillation by increasing what doctors know about cardiac ablation of atrial fibrillation.
- Review the patient informed consent form and ask questions
- Talk it over with family and your own doctor if you wish
- Decide whether to participate
- If you agree to participate, contact your Zero AF Study Center to arrange a screening appointment