Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Hans-Peter Stoll, MD, PhD 646-956-2161
hpstoll@orchestrabiomed.com


Angela Stagg astagg@orchestrabiomed.com


Study Location:

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English | Cymraeg
Be Part of Research - Trial Details - BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Hypertension
Bradycardia
Essential Hypertension
Isolated Systolic Hypertension


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2023 Oct 2026

Publications

"Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13."; "34387126"; "Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974."; "29275370"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Antihypertensive therapy utilizing atrioventricular interval modulation.

Intervention Arm Group : Treatment Group;

Intervention Type : DEVICE
Intervention Description : AVIM therapy is deactivated

Intervention Arm Group : Control Group;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • John Radcliffe Hospital
    Oxford
  • Royal Brompton
    London
  • St. Bartholomew's Hospital
    London
  • St. Thomas Hospital
    London
  • Southampton General Hospital
    Southhampton


The study is sponsored by Orchestra BioMed, Inc and is in collaboration with Medtronic.




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Read full details for Trial ID: NCT06059638
Last updated 27 June 2025

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