NCT06059638

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Orchestra BioMed, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypertension
• Hypertension, Systolic
• Hypertension, Essential

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-27
• Primary completion: 2026-12-01
• Completion: 2029-08-01
• First posted: 2023-09-28
• Last updated: 2026-04-17

Locations

99 sites across 11 countries: United States, Australia, Belgium, Czechia, Germany, Hungary, Netherlands, New Zealand, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated device study