BACKBEAT Trial) (BACKBEAT)

Evaluating Investigational Algorithm for Heart Pacemakers in Patients with Hypertension and Dual-Chamber Pacemaker

Recruiting
18 years or above
All
Phase N/A
500 participants needed
1 Location

Brief description of 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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hypertension, Hypertension, Systolic, Hypertension, Essential
  • Age: 18 years or above
  • Gender: All

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

This study investigates the safety and effectiveness of an investigational atrioventricular interval modulation (AVIM) algorithm in patients with dual-chamber pacemakers.

The study evaluates how well the investigational AVIM algorithm works when downloaded into a specific type of pacemaker. It looks at whether this algorithm can be safely used and how effective it is in managing the condition.

  • Who can participate: Adults 18 years and older who have or need a dual-chamber pacemaker and have stable blood pressure medication are eligible. Blood pressure must be between 135 mmHg and 180 mmHg to qualify.
  • Study details: Participants will have their pacemaker settings adjusted to either turn on or off the investigational therapy. They will continue their usual blood pressure medication. A placebo is not part of this study.
  • Study timelines: The study will last 1 year for the Double-blind Randomized Phase and 2 years for the Unblinded Phase.
Updated on 09 Jul 2026. Study ID: 23-1793

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