You may be able to take part in a clinical research study.
What is PSVT?
PSVT is a condition where the heart sometimes beats faster than normal (60-100 beats per minute). This happens when the electrical signals controlling the heartbeat are not working properly. During a PSVT episode, patients may feel palpitations (rapid heartbeat) caused by an increased heart rate of more than 100 beats per minute.
Although PSVT is typically not a lifethreatening condition, it may result in a trip to the emergency department to receive intravenous treatment (and possibly other treatments) to get the heartbeat back to normal. Other treatment options may include an invasive surgical ~ procedure that scars the heart to fix abnormal electrical signals.
What is the NODE-303 Study?
NODE -303 is a clinical research study that aims to enroll 3000 people with PSVT.
The purpose of the study is to determine how safe an investigational medication is to use at home and whether it works for people having an episode of PSVT.
What is the investigational medication?
The NODE -303 Study will test whether an investigational medication, called etripamii, can quickly and safely end a PSVT episode. The investigational medication belongs to a class of drugs known as calcium channel blockers, and it is taken as a nasal spray. The nasal spray is portable and designed so that patients can take it themselves when having a PSVT episode.
“Investigational” means the medication has not been approved by any regulatory agency.
Who can participate in the study?
Thousands of people all around the world take part in clinical research studies each year. These studies can only take place if they enroll the right people. You may be able to take part in this study if you:
• are 18 years of age or older.
• have been diagnosed with PSVT.
• have had at least 1 previous episode of PSVT.
There will also be some other requirements.
What will happen in the study?
If you join the NODE-303 Study, you will be given a cardiac monitoring system (CMS) to monitor your heartbeat. When having an episode of PSVT, you will be asked to apply the CMS. You will then perform a vagal maneuver/ and if the symptoms do not resolve/ you will take the investigational medication.
You will remain in the study until you have taken 1 dose of the investigational nasal spray. You may be able to continue in the study until you have taken up to 4 doses. You will visit the study center up to 6 times.
Screening visit
You will visit the study center to see if th e study is right for you and whether you want to take part.
Baseline visit
If the study is right for you, you will visit the study center and receive a take-home kit. The kit includes the investigational medication and the CMS.
Treatment period and follow-up visits
Every month you will be asked to answer some questions about your PSVT episodes using an application on your phone or tablet. If you have an episode of PSVT, you will:
• use the CMS to record the episode.
• follow the instructions in your kit and take the investigational nasal spray when needed.
• have a follow-up visit at the study center for assessments within 14 days of taking the investigational nasal spray.
Final study visit
After your fourth dose of the investigational nasal spray, or if you decide to leave the study early, you will visit the study center for final assessments and to return all study materials.
What are the benefits and risks of participation?
There are potential benefits and risks in any clinical study. You should only enroll in the study after careful discussion with the study doctor.
Potential benefits of participating in this study include:
• the possibility of managing an episode of PSVT at home.
• receiving the investigational medication as well as close monitoring and care during the study by a health care team experienced in clinical research studies.
• the possibility of helping others suffering from PSVT episodes find more convenient treatment options in the future.
Potential risks of participating in the study include:
• experiencing side effects from the investigational medication or risks that are not yet known.
• seeing no improvement in your condition.
For more information about the NODE-303 Study, contact the study center directly at:
Advanced Research for Health Improvement, LLC
1168 Goodlette Rd. N., Naples, FL 34102
239-230-2021
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