At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated (device), Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated (device)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated — device: Antihypertensive therapy utilizing atrioventricular interval modulation. · Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated — device: AVIM therapy is deactivated
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 316
- Started
- 2023-12-27
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for hypertension
- • NA - 316 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hypertension
Where?
- • London - Royal Brompton
- • London - St. Bartholomew's Hospital
- • London - St. Thomas Hospital
- • Oxford - John Radcliffe Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized Phase (1 year), and 3) Unblinded Phase (2 years). Patients scheduled for implantation of an Astra/Azure pacemaker, or those who already have one implanted, who also have hypertension, may be screened for inclusion into this study. Subjects meeting randomization eligibility criteria will have the investigational AVIM Therapy RAMware downloaded into the Astra/Azure pacemaker and be randomized 1:1 to either have AVIM therapy turned ON or turned OFF. All subjects will continue to receive antihypertensive drug therapy.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (5 UK sites)
Royal Brompton
London, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
St. Thomas Hospital
London, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Southampton General Hospital
Southhampton, United Kingdom
How to Get in Touch
Steven J. Evans, MD
Sponsor contactCONTACT
Angela Stagg
Sponsor contactCONTACT