NCT06059638ClinicalTrials.gov

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

En recrutementAccepte des participants actuellement, selon la fiche du registre.

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En bref

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.

Interventionnelle316 participants recherchés131 sites15 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

ClinicalTrials.govNCT06059638Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 4 semaines

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

Hypertension
Hypertension, Systolic
Hypertension, Essential

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Sans objet
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	TRIPLE (3)
Recrutement	316 participants recherchés

Promoteur et collaborateurs

Orchestra BioMed, Inc Promoteur
Medtronic Collaborateurs

Groupes et 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

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

Critères de jugement

Critère de jugement principal
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
Délai Baseline and 3 months post randomization
Critère de jugement principal
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
Délai 3 months post randomization

Dates

Dates
Date de début	27 décembre 2023 (réelle)
Achèvement principal	1 décembre 2026 (estimée)
Achèvement	1 août 2029 (estimée)
Première publication	28 septembre 2023 (réelle)
Dernière mise à jour	26 août 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	août 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

111 sites sont en recrutement

Australia

Australia
Établissement	Ville	État ou région	Statut
Lyell McEwin Hospital	Elizabeth Vale	South Australia	En recrutement

Belgium

Belgium
Établissement	Ville	Statut
OLV Ziekenhuis	Aalst	Retiré
Middelheim Ziekenhuis	Antwerp	En recrutement
Universite Libre de Bruxelles-Erasme Hospital	Brussels	En recrutement
UZ Brussel	Brussels	Retiré
UZ Leuven	Leuven	En recrutement

China

China
Établissement	Ville	État ou région	Statut
Jiangsu Province Hospital	Nanjing		En recrutement
Nanjing Drum Tower Hospital	Nanjing	Jiangsu	En recrutement

Czechia

Czechia
Établissement	Ville	Statut
Institute for Clinical and Experimental Medicine (IKEM)	Prague	En recrutement
Fakultní nemocnice Královské Vinohrady (FNKV)	Prague	En recrutement
Na Homolce Hospital	Prague	En recrutement

France

France
Établissement	Ville	Statut
CHU Grenoble	Grenoble	En recrutement
Hospices Civils de Lyon (HCL)	Lyon	En recrutement
CHU de Nantes	Nantes	En recrutement
AP-HP Hôpital Pitié Salpêtrière	Paris	En recrutement
CHRU Tours	Tours	En recrutement

Germany

Germany
Établissement	Ville	Statut
Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)	Berlin	En recrutement
Herzzentrum Bonn am Universitätsklinikum Bonn	Bonn	En recrutement
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus	Frankfurt	En recrutement
Universitätsklinikum Hamburg-Eppendorf	Hamburg	En recrutement
Herzzentrum Leipzig	Leipzig	Pas encore en recrutement
University Hospital Luebeck	Lübeck	En recrutement
University Medical Centre Mannheim	Mannheim	En recrutement
Saarland University Hospital	Saarbrücken	En recrutement
Krankenhaus der Barmherzigen Brüder Trier	Trier	En recrutement

Hungary

Hungary
Établissement	Ville	Statut
Central Hospital of Northern Pest - Military Hospital	Budapest	En recrutement
Semmelweis University	Budapest	En recrutement
University of Debrecen	Debrecen	En recrutement
University of Szeged	Szeged	En recrutement

Italy

Italy
Établissement	Ville	Statut
Policlinico Di Sant Orsola Malpighi	Bologna	En recrutement
Campus Bio-Medico University Hospital	Rome	En recrutement
Azienda Ospedaliera Universitaria Integrata Verona	Verona	En recrutement
IRCCS Sacro Cuore Don Calabria	Verona	En recrutement

Netherlands

Netherlands
Établissement	Ville	Statut
Amsterdam University Medical Centre	Amsterdam	En recrutement
Maastricht UMC+	Maastricht	En recrutement
Isala Klinieken	Zwolle	En recrutement

New Zealand

New Zealand
Établissement	Ville	État ou région	Statut
ChristChurch Hospital	Christchurch	Canterbury	En recrutement

Poland

Poland
Établissement	Ville	Statut
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach	Katowice	En recrutement
Jagiellonian University Hospital	Krakow	En recrutement
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi	Lodz	Pas encore en recrutement
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego	Lublin	En recrutement
Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan	En recrutement
Uniwersytecki Szpital Kliniczny nr 2 PUM	Szczecin	En recrutement
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	En recrutement
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu	Wroclaw	En recrutement
Silesian Center for Heart Diseases	Zabrze	En recrutement

Spain

Spain
Établissement	Ville	Statut
Hospital Germans Trias i Pujol	Badalona	En recrutement
Hospital Clínico de Barcelona	Barcelona	En recrutement
La Paz University Hospital	Madrid	En recrutement
Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife	En recrutement

81 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

26 août 2026
Objectif de recrutement modifié
Enrollment target revised down from 500 to 316
500316

Registre: ClinicalTrials.gov · NCT########

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