RecruitingNot ApplicableNCT06059638
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Sponsor
Orchestra BioMed, Inc
Enrollment
500 participants
Start Date
Dec 27, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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
Exclusion Criteria10
- 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
Interventions
DEVICEMedtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
DEVICEMedtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated
Locations(98)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06059638
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