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BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

NCT06059638 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Hypertension
  • Hypertension, Systolic
  • Hypertension, Essential

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Orchestra BioMed, Inc

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Heart Institute

  • Andrea Russo, MD · Cooper University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2026-12-31
Completion
2029-08-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059638 on ClinicalTrials.gov