BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
This research is investigating if a specific setting, called AVIM therapy, in a Medtronic pacemaker can help manage high blood pressure. Patients who either need a dual-chamber pacemaker or already have one, and are also dealing with high blood pressure, might be able to take part. The study will randomly assign participants to have this special pacemaker setting either turned on or kept off, without them or their doctors knowing which group they are in. Everyone will continue their usual blood pressure medication. The main aim is to see if this pacemaker setting is both safe and effective for treating high blood pressure.
At a glance
What is this study about?
This study is looking into a new way to help people with high blood pressure. It focuses on a special feature built into certain Medtronic heart pacemakers, called AV interval modulation (AVIM) therapy. A pacemaker is a small device placed in your chest that helps control your heartbeat. The researchers want to find out if turning this AVIM feature on can make a difference in lowering blood pressure.
To do this, they will be studying people who either need a dual-chamber Medtronic Astra or Azure pacemaker, or already have one fitted. These participants must also have high blood pressure. The study will be run in several countries and will compare what happens when the AVIM therapy is active versus when it is not.
It’s important to know that everyone in the study will continue to take their usual blood pressure medications. This study is designed to be 'double-blind,' which means neither the patients nor their doctors will know whether the AVIM feature in the pacemaker is turned on or off. This helps make sure the results are as fair and accurate as possible.
Key takeaways
- Tests a new pacemaker feature for high blood pressure.
- For people who need or have a Medtronic Astra/Azure pacemaker and high blood pressure.
- Participants continue their regular blood pressure medicine.
- Neither you nor your doctor will know if the feature is active for the first year.
- The study lasts for three years to check safety and effectiveness.
Who may be eligible?
You might be able to join this study if you are 18 years old or older and have high blood pressure. You would also need to either be scheduled to get a specific type of Medtronic pacemaker (Astra or Azure dual-chamber model) or already have one fitted. You should also be on a steady routine of at least one type of blood pressure medication, and your blood pressure readings, both in the doctor's office and over 24 hours, need to be within a certain high range.
However, there are reasons you might not be able to join. For instance, if your heart's pumping ability is too low, or if you have severe heart failure symptoms. You also can't take part if you've had a stroke or mini-stroke in the last 6 months, or a heart attack or certain heart/blood vessel procedures in the last 3 months. Other conditions like a specific type of irregular heartbeat (permanent atrial fibrillation) or severe problems with certain heart valves would also prevent you from joining. Similarly, if you've had other device-based treatments for blood pressure or have another active heart device or nerve stimulator (apart from the Medtronic Astra/Azure pacemaker being studied) then you won't be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older and have high blood pressure?
- Do you need a Medtronic Astra/Azure dual-chamber pacemaker or already have one?
- Are you currently taking at least one blood pressure medication?
- Are your recent blood pressure readings still higher than normal, even with medication?
- Have you *not* had a stroke or heart attack recently (within the last 6 months/3 months)?
- Do you *not* have other severe heart conditions like permanent atrial fibrillation or very poor heart pumping ability?
What does participation involve?
If you decide to take part, the study will last for three years in total. First, there's a 'screening phase' to check if you're suitable for the study. If you are, and you're getting a new Medtronic Astra/Azure pacemaker, or already have one, a special software for the AVIM therapy will be downloaded onto it. You will then be randomly assigned, like flipping a coin, to either have this AVIM therapy turned on or kept off for the first year. Neither you nor your doctor will know which group you are in during this time.
Throughout the study, you'll continue to take your regular blood pressure medications. There will be regular visits to the clinic so the research team can monitor your blood pressure and overall health. After the first year, it will be revealed whether your AVIM therapy was on or off, and the study will continue for another two years to see long-term effects. The research team will explain all visits and assessments in detail.
Potential risks and benefits
Locations (129)
- HonorHealthVerified postcodeScottsdale, United States· Recruiting
- Adventist Health GlendaleVerified postcodeGlendale, United States· Recruiting
- Hoag Memorial Hospital PresbyterianVerified postcodeNewport Beach, United States· Recruiting
- StanfordVerified postcodeRedwood City, United States· Recruiting
- Scripps ClinicVerified postcodeSan Diego, United States· Recruiting
- Sutter Valley HospitalsVerified postcodeSan Francisco, United States· Recruiting
- South Denver CardiologyVerified postcodeDenver, United States· Recruiting
- Colorado Heart and VascularVerified postcodeGolden, United States· Recruiting
- Intermountain Health Lutheran HospitalVerified postcodeGolden, United States· Recruiting
- MedStar Washington Hospital CenterVerified postcodeWashington D.C., United States· Recruiting
- HCA Florida JFK HospitalVerified postcodeAtlantis, United States· Recruiting
- Cardiovascular Research Solutions (MyCardiologist)Verified postcodeCelebration, United States· Recruiting
Common questions
What is a pacemaker?
A pacemaker is a small device put in your chest to help regulate your heartbeat if your heart beats too slowly or irregularly.
What is AVIM therapy?
AVIM therapy is a special feature in some pacemakers that might help manage high blood pressure by adjusting how your heart chambers beat together.
Will I still need my blood pressure medication?
Yes, everyone in the study will continue to take their usual blood pressure medications.
How long will the study last?
The study will last for three years in total, with an initial one-year period where you won't know if the therapy is on or off.
Is this a new type of pacemaker?
No, this study uses existing Medtronic Astra/Azure pacemakers but investigates a new software feature within them.
How to find out more
Hans-Peter Stoll, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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