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RecruitingNot applicable

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new program added to a Medtronic Astra/Azure pacemaker that helps control two heart chambers. The program changes the timing between the chambers to treat high blood pressure. The study checks its safety and how well it works in people who have or need this pacemaker.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have or need a pacemaker that helps control two heart chambers. The first visit can be within 30 days before a planned Medtronic Astra/Azure implant or any time after.
  • Be on a steady treatment plan with at least one type of blood pressure medicine.
  • Have a top blood pressure number of at least 135 but below 180 mmHg at an office visit.
  • Have an average top blood pressure number of at least 130 but below 170 mmHg when measured over 24 hours.

Who can't join

  • The heart's main pumping chamber pumps out less than 50% of its blood with each beat, or heart failure causes symptoms with light activity or at rest.
  • Had a stroke or a TIA (a short-term stroke-like event) within 6 months.
  • Had a heart attack within 3 months.
  • Had a procedure or surgery on heart arteries, neck arteries, or inside blood vessels within 3 months.
  • Have permanent atrial fibrillation, an ongoing irregular heartbeat.
  • Have a mitral heart valve leak rated grade 3 or higher, or a narrowed aortic heart valve with an opening smaller than 1.5 square centimeters.
  • Have or previously had a device-based treatment for high blood pressure, such as treatment of kidney nerves or electrical stimulation to lower blood pressure.
  • Have another active heart device or a device that stimulates nerves, besides the recently implanted Astra/Azure pacemaker.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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 2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug 3. Office SBP ≥135 mmHg and \<180 mmHg 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg Exclusion Criteria: 1. LVEF \<50% 2. NYHA Class III-IV 3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months 4. Myocardial infarction (MI) within 3 months 5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months 6. Permanent atrial fibrillation 7. Mitral valve regurgitation greater than or equal to grade 3 8. Aortic stenosis with a valve area less than 1.5 cm2 9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy) 10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Study sites (72)

AZ

CA

CO

DC

FL

GA

ID

IL

KS

KY

LA

MA

MD

MI

MN

MO

NC

NJ

NM

NY

OH

OK

PA

SC

TN

TX

VA

WI

WV