Heart & Vascular Clinical Trials
BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)
Learn moreWhat is the purpose of this study?
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
- 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
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
- Disease Type/ConditionHypertension, Hypertension, Systolic, Hypertension Essential
- Principal InvestigatorEdward Kim, MD
- Co-InvestigatorsRajesh Banker, MD
- Age GroupAdult, Older Adult
- PhaseN/A
- ClinicalTrials.gov IDNCT06059638
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Jeffrey M. Carlton Heart & Vascular Institute
Hoag’s Jeffrey M. Carlton Heart & Vascular Institute provides advanced, coordinated care for complex heart and vascular conditions, bringing together nationally recognized cardiologists, cardiac surgeons, electrophysiologists, heart failure specialists, and vascular experts. Patients have access to comprehensive evaluation, leading cardiovascular programs, advanced treatment options, and clinical trials designed to help identify the right path forward.
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