BACKBEAT

BradycArdia Pacemaker With AV Interval Modulation for Blood Pressure Treatment

Objective

The purpose of this study is to evaluate the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG.

Study Arms

Experimental: Treatment Group:

• AVIM therapy activated with continued stable antihypertensive drug therapy
• Interventions:
  • Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Sham Comparator: Control Group:

• AVIM therapy deactivated with continued stable antihypertensive drug therapy
• Interventions:
  • Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Eligibility

1. Within 90 days of a de novo implant of a Medtronic Astra/Azure dual chamber pacemaker and Medtronic pacing leads
2. On a stable antihypertension treatment regimen with 1, 2 or 3 classes of antihypertensive drugs
3. Office SBP ≥140 mmHg and <180 mmHg
4. Average 24-Hour aSBP ≥130 mmHg and <170 mmHg

NCT ID

NCT06059638