BridgeMD
New treatment option for Hypertension
Official title BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
ClinicalTrials.gov ID: NCT06059638
What this study is testing
- What it's testing
- A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic...
- On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
- Office SBP ≥135 mmHg and \<180 mmHg
- Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
You likely can't join if
- LVEF \<50%
- NYHA Class III-IV
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
- Myocardial infarction (MI) within 3 months
- Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
- Permanent atrial fibrillation
See the full eligibility criteria
- Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamber pacemaker system or at any time thereafter
- On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
- Office SBP ≥135 mmHg and \<180 mmHg
- Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
- LVEF \<50%
- NYHA Class III-IV
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
- Myocardial infarction (MI) within 3 months
- Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
- Permanent atrial fibrillation
- Mitral valve regurgitation greater than or equal to grade 3
- Aortic stenosis with a valve area less than 1.5 cm2
- Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
- Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Glendale, California, United States
- Newport Beach, California, United States
- Redwood City, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Golden, Colorado, United States
- Loveland, Colorado, United States
- Washington D.C., District of Columbia, United States
- Atlantis, Florida, United States
- Celebration, Florida, United States
- Clearwater, Florida, United States
- Crystal River, Florida, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Sarasota, Florida, United States
+ 95 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Glendale, California, United States; Newport Beach, California, United States; Redwood City, California, United States; San Diego, California, United States; San Francisco, California, United States and 109 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.