NCT06059638ClinicalTrials.gov

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

RecruitingTaking participants now, according to the registry record.

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In brief

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.

Interventional316 participants sought131 sites15 countries

Registered in 1 registry

ClinicalTrials.govNCT06059638Open this record at ClinicalTrials.govSynced 4 weeks ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2023-09-28; recorded start 2023-12-27
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Orchestra BioMed, Inc)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding16/20
Triple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 131 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 316 participants (target), run at 131 sites, across 15 countries.

How this score is built

Enrolment26/40
500 participants (target)
Site count23/25
131 sites
Country count12/15
15 countries
Planned duration10/10
Planned over about 68 months
Sponsor scale1/10
Orchestra BioMed, Inc has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria: 1. 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 2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug 3. Office SBP ≥135 mmHg and \<180 mmHg 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg Exclusion Criteria: 1. LVEF \<50% 2. NYHA Class III-IV 3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months 4. Myocardial infarction (MI) within 3 months 5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months 6. Permanent atrial fibrillation 7. Mitral valve regurgitation greater than or equal to grade 3 8. Aortic stenosis with a valve area less than 1.5 cm2 9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy) 10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Not applicable
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	TRIPLE (3)
Enrolment	316 participants sought

Sponsor and collaborators

Orchestra BioMed, Inc Sponsor
Medtronic Collaborators

Arms and interventions

Treatment GroupEXPERIMENTAL
AVIM therapy activated with continued stable antihypertensive drug therapy
Control GroupSHAM_COMPARATOR
AVIM therapy deactivated with continued stable antihypertensive drug therapy

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

Outcome measures

Primary outcome
Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Time frame Baseline and 3 months post randomization
Primary outcome
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
Time frame 3 months post randomization

Dates

Dates
Start date	December 27, 2023 (actual)
Primary completion	December 1, 2026 (estimated)
Completion	August 1, 2029 (estimated)
First posted	September 28, 2023 (actual)
Last updated	August 26, 2026
Results posted	Not stated in the registry record
Status last verified	August 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

111 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Lyell McEwin Hospital	Elizabeth Vale	South Australia	Recruiting

Belgium

Belgium
Facility	City	Status
OLV Ziekenhuis	Aalst	Withdrawn
Middelheim Ziekenhuis	Antwerp	Recruiting
Universite Libre de Bruxelles-Erasme Hospital	Brussels	Recruiting
UZ Brussel	Brussels	Withdrawn
UZ Leuven	Leuven	Recruiting

China

China
Facility	City	State or region	Status
Jiangsu Province Hospital	Nanjing		Recruiting
Nanjing Drum Tower Hospital	Nanjing	Jiangsu	Recruiting

Czechia

Czechia
Facility	City	Status
Institute for Clinical and Experimental Medicine (IKEM)	Prague	Recruiting
Fakultní nemocnice Královské Vinohrady (FNKV)	Prague	Recruiting
Na Homolce Hospital	Prague	Recruiting

France

France
Facility	City	Status
CHU Grenoble	Grenoble	Recruiting
Hospices Civils de Lyon (HCL)	Lyon	Recruiting
CHU de Nantes	Nantes	Recruiting
AP-HP Hôpital Pitié Salpêtrière	Paris	Recruiting
CHRU Tours	Tours	Recruiting

Germany

Germany
Facility	City	Status
Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)	Berlin	Recruiting
Herzzentrum Bonn am Universitätsklinikum Bonn	Bonn	Recruiting
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus	Frankfurt	Recruiting
Universitätsklinikum Hamburg-Eppendorf	Hamburg	Recruiting
Herzzentrum Leipzig	Leipzig	Not yet recruiting
University Hospital Luebeck	Lübeck	Recruiting
University Medical Centre Mannheim	Mannheim	Recruiting
Saarland University Hospital	Saarbrücken	Recruiting
Krankenhaus der Barmherzigen Brüder Trier	Trier	Recruiting

Hungary

Hungary
Facility	City	Status
Central Hospital of Northern Pest - Military Hospital	Budapest	Recruiting
Semmelweis University	Budapest	Recruiting
University of Debrecen	Debrecen	Recruiting
University of Szeged	Szeged	Recruiting

Italy

Italy
Facility	City	Status
Policlinico Di Sant Orsola Malpighi	Bologna	Recruiting
Campus Bio-Medico University Hospital	Rome	Recruiting
Azienda Ospedaliera Universitaria Integrata Verona	Verona	Recruiting
IRCCS Sacro Cuore Don Calabria	Verona	Recruiting

Netherlands

Netherlands
Facility	City	Status
Amsterdam University Medical Centre	Amsterdam	Recruiting
Maastricht UMC+	Maastricht	Recruiting
Isala Klinieken	Zwolle	Recruiting

New Zealand

New Zealand
Facility	City	State or region	Status
ChristChurch Hospital	Christchurch	Canterbury	Recruiting

Poland

Poland
Facility	City	Status
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach	Katowice	Recruiting
Jagiellonian University Hospital	Krakow	Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi	Lodz	Not yet recruiting
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego	Lublin	Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan	Recruiting
Uniwersytecki Szpital Kliniczny nr 2 PUM	Szczecin	Recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu	Wroclaw	Recruiting
Silesian Center for Heart Diseases	Zabrze	Recruiting

Spain

Spain
Facility	City	Status
Hospital Germans Trias i Pujol	Badalona	Recruiting
Hospital Clínico de Barcelona	Barcelona	Recruiting
La Paz University Hospital	Madrid	Recruiting
Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife	Recruiting

81 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

August 26, 2026
Enrolment target changed
Enrollment target revised down from 500 to 316
500316

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06059638

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Australia

Belgium

China

Czechia

France

Germany

Hungary

Italy

Netherlands

New Zealand

Poland

Spain

Study documents

Changes over time