Pacemaker Timing Adjustment Tested for High Blood Pressure
Tests a pacemaker timing setting in adults with high blood pressure.
Plain-language title generated from the registry record
Registry title: BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Key facts
- Where
- Katowice, Krakow, Lodz, Lublin, Poznan, Szczecin, Warsaw, Wroclaw, and Zabrze, PolandSee the 9 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high blood pressure who have, or are indicated for, a dual-chamber pacemaker and take blood pressure medicine.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Office systolic blood pressure of at least 135 mmHg and below 180 mmHg. Average 24-hour systolic blood pressure of at least 130 mmHg and below 170 mmHg.
- Earlier treatment
- Must be on a stable blood pressure treatment with at least 1 class of antihypertensive drug. Must not have had a device-based blood pressure treatment, such as renal denervation or baroreflex activation therapy.
Main reasons for not taking part
- Heart pumping strength (LVEF) below 50%
- NYHA Class III-IV heart failure
- Stroke or transient ischemic attack within 6 months
- Heart attack within 3 months
- Permanent atrial fibrillation
Read by machine on 9 November 2026.
Where in Poland
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandTaking people
- Jagiellonian University HospitalKrakow, PolandTaking people
- Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziLodz, PolandTaking people
- Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała WyszyńskiegoLublin, PolandTaking people
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandTaking people
- Uniwersytecki Szpital Kliniczny nr 2 PUMSzczecin, PolandTaking people
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, PolandTaking people
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuWroclaw, PolandTaking people
- Silesian Center for Heart DiseasesZabrze, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Orchestra BioMed, Inc
- Trial code
- NCT06059638
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
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.
Inclusion: 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; On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug; Office SBP ≥135 mmHg and <180 mmHg; Average 24-Hour aSBP ≥130 mmHg and <170 mmHg.
Exclusion: Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months; Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy); History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months; Myocardial infarction (MI) within 3 months; Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant; LVEF <50%; NYHA Class III-IV; Permanent atrial fibrillation; Mitral valve regurgitation greater than or equal to grade 3; Aortic stenosis with a valve area less than 1.5 cm2.