Recruiting NCT06059638

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

No phase Interventional Hypertension Hypertension, Systolic Hypertension, Essential

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated, Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated.
Who it may be relevant to: Registry conditions: Hypertension, Hypertension, Systolic, Hypertension, Essential. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, China, Czechia +10
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

Device Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
Device Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated

Primary outcome measures

Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months [Time frame: Baseline and 3 months post randomization]
Freedom from Unanticipated Serious Adverse Device Effects (USADE) [Time frame: 3 months post randomization]

Eligibility criteria

Inclusion 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment