NCT06059638ClinicalTrials.gov

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

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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.

Interventionell316 Teilnehmende gesucht131 Studienzentren15 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT06059638Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 4 Wochen

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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.

Zusammenfassung

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.

Erkrankungen

Hypertension
Hypertension, Systolic
Hypertension, Essential

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	TRIPLE (3)
Teilnahme	316 Teilnehmende gesucht

Sponsor und Mitwirkende

Orchestra BioMed, Inc Sponsor
Medtronic Mitwirkende

Studienarme und Interventionen

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

Interventionen

Medizinprodukt Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
Medizinprodukt Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated

Endpunkte

Primärer Endpunkt
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
Zeitrahmen Baseline and 3 months post randomization
Primärer Endpunkt
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
Zeitrahmen 3 months post randomization

Daten

Daten
Startdatum	27. Dezember 2023 (tatsächlich)
Primärer Abschluss	1. Dezember 2026 (geschätzt)
Abschluss	1. August 2029 (geschätzt)
Erstveröffentlichung	28. September 2023 (tatsächlich)
Zuletzt aktualisiert	26. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

111 Studienzentren rekrutieren

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Lyell McEwin Hospital	Elizabeth Vale	South Australia	Rekrutiert

Belgium

Belgium
Einrichtung	Stadt	Status
OLV Ziekenhuis	Aalst	Zurückgezogen
Middelheim Ziekenhuis	Antwerp	Rekrutiert
Universite Libre de Bruxelles-Erasme Hospital	Brussels	Rekrutiert
UZ Brussel	Brussels	Zurückgezogen
UZ Leuven	Leuven	Rekrutiert

China

China
Einrichtung	Stadt	Bundesland oder Region	Status
Jiangsu Province Hospital	Nanjing		Rekrutiert
Nanjing Drum Tower Hospital	Nanjing	Jiangsu	Rekrutiert

Czechia

Czechia
Einrichtung	Stadt	Status
Institute for Clinical and Experimental Medicine (IKEM)	Prague	Rekrutiert
Fakultní nemocnice Královské Vinohrady (FNKV)	Prague	Rekrutiert
Na Homolce Hospital	Prague	Rekrutiert

France

France
Einrichtung	Stadt	Status
CHU Grenoble	Grenoble	Rekrutiert
Hospices Civils de Lyon (HCL)	Lyon	Rekrutiert
CHU de Nantes	Nantes	Rekrutiert
AP-HP Hôpital Pitié Salpêtrière	Paris	Rekrutiert
CHRU Tours	Tours	Rekrutiert

Germany

Germany
Einrichtung	Stadt	Status
Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)	Berlin	Rekrutiert
Herzzentrum Bonn am Universitätsklinikum Bonn	Bonn	Rekrutiert
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus	Frankfurt	Rekrutiert
Universitätsklinikum Hamburg-Eppendorf	Hamburg	Rekrutiert
Herzzentrum Leipzig	Leipzig	Rekrutierung noch nicht begonnen
University Hospital Luebeck	Lübeck	Rekrutiert
University Medical Centre Mannheim	Mannheim	Rekrutiert
Saarland University Hospital	Saarbrücken	Rekrutiert
Krankenhaus der Barmherzigen Brüder Trier	Trier	Rekrutiert

Hungary

Hungary
Einrichtung	Stadt	Status
Central Hospital of Northern Pest - Military Hospital	Budapest	Rekrutiert
Semmelweis University	Budapest	Rekrutiert
University of Debrecen	Debrecen	Rekrutiert
University of Szeged	Szeged	Rekrutiert

Italy

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

Netherlands

Netherlands
Einrichtung	Stadt	Status
Amsterdam University Medical Centre	Amsterdam	Rekrutiert
Maastricht UMC+	Maastricht	Rekrutiert
Isala Klinieken	Zwolle	Rekrutiert

New Zealand

New Zealand
Einrichtung	Stadt	Bundesland oder Region	Status
ChristChurch Hospital	Christchurch	Canterbury	Rekrutiert

Poland

Poland
Einrichtung	Stadt	Status
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach	Katowice	Rekrutiert
Jagiellonian University Hospital	Krakow	Rekrutiert
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi	Lodz	Rekrutierung noch nicht begonnen
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego	Lublin	Rekrutiert
Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan	Rekrutiert
Uniwersytecki Szpital Kliniczny nr 2 PUM	Szczecin	Rekrutiert
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Rekrutiert
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu	Wroclaw	Rekrutiert
Silesian Center for Heart Diseases	Zabrze	Rekrutiert

Spain

Spain
Einrichtung	Stadt	Status
Hospital Germans Trias i Pujol	Badalona	Rekrutiert
Hospital Clínico de Barcelona	Barcelona	Rekrutiert
La Paz University Hospital	Madrid	Rekrutiert
Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife	Rekrutiert

81 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

26. August 2026
Teilnahmeziel geändert
Enrollment target revised down from 500 to 316
500316

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