NCT06059638ClinicalTrials.gov

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

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En resumen

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.

De intervención316 participantes buscados131 centros15 países

Categorías

Cardiovascular100%

Registrado en 1 registro

ClinicalTrials.govNCT06059638Abrir este registro en ClinicalTrials.govSincronizado hace 4 semanas

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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.

Resumen

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.

Afecciones

Hypertension
Hypertension, Systolic
Hypertension, Essential

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	No aplicable
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	TRIPLE (3)
Inscripción	316 participantes buscados

Patrocinador y colaboradores

Orchestra BioMed, Inc Patrocinador
Medtronic Colaboradores

Grupos e intervenciones

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

Intervenciones

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

Variables de resultado

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

Fechas

Fechas
Fecha de inicio	27 de diciembre de 2023 (real)
Finalización principal	1 de diciembre de 2026 (estimada)
Finalización	1 de agosto de 2029 (estimada)
Primera publicación	28 de septiembre de 2023 (real)
Última actualización	26 de agosto de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	agosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

111 centros están en reclutamiento

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Lyell McEwin Hospital	Elizabeth Vale	South Australia	En reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado
OLV Ziekenhuis	Aalst	Retirado
Middelheim Ziekenhuis	Antwerp	En reclutamiento
Universite Libre de Bruxelles-Erasme Hospital	Brussels	En reclutamiento
UZ Brussel	Brussels	Retirado
UZ Leuven	Leuven	En reclutamiento

China

China
Centro	Ciudad	Estado o región	Estado
Jiangsu Province Hospital	Nanjing		En reclutamiento
Nanjing Drum Tower Hospital	Nanjing	Jiangsu	En reclutamiento

Czechia

Czechia
Centro	Ciudad	Estado
Institute for Clinical and Experimental Medicine (IKEM)	Prague	En reclutamiento
Fakultní nemocnice Královské Vinohrady (FNKV)	Prague	En reclutamiento
Na Homolce Hospital	Prague	En reclutamiento

France

France
Centro	Ciudad	Estado
CHU Grenoble	Grenoble	En reclutamiento
Hospices Civils de Lyon (HCL)	Lyon	En reclutamiento
CHU de Nantes	Nantes	En reclutamiento
AP-HP Hôpital Pitié Salpêtrière	Paris	En reclutamiento
CHRU Tours	Tours	En reclutamiento

Germany

Germany
Centro	Ciudad	Estado
Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)	Berlin	En reclutamiento
Herzzentrum Bonn am Universitätsklinikum Bonn	Bonn	En reclutamiento
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus	Frankfurt	En reclutamiento
Universitätsklinikum Hamburg-Eppendorf	Hamburg	En reclutamiento
Herzzentrum Leipzig	Leipzig	Aún no recluta
University Hospital Luebeck	Lübeck	En reclutamiento
University Medical Centre Mannheim	Mannheim	En reclutamiento
Saarland University Hospital	Saarbrücken	En reclutamiento
Krankenhaus der Barmherzigen Brüder Trier	Trier	En reclutamiento

Hungary

Hungary
Centro	Ciudad	Estado
Central Hospital of Northern Pest - Military Hospital	Budapest	En reclutamiento
Semmelweis University	Budapest	En reclutamiento
University of Debrecen	Debrecen	En reclutamiento
University of Szeged	Szeged	En reclutamiento

Italy

Italy
Centro	Ciudad	Estado
Policlinico Di Sant Orsola Malpighi	Bologna	En reclutamiento
Campus Bio-Medico University Hospital	Rome	En reclutamiento
Azienda Ospedaliera Universitaria Integrata Verona	Verona	En reclutamiento
IRCCS Sacro Cuore Don Calabria	Verona	En reclutamiento

Netherlands

Netherlands
Centro	Ciudad	Estado
Amsterdam University Medical Centre	Amsterdam	En reclutamiento
Maastricht UMC+	Maastricht	En reclutamiento
Isala Klinieken	Zwolle	En reclutamiento

New Zealand

New Zealand
Centro	Ciudad	Estado o región	Estado
ChristChurch Hospital	Christchurch	Canterbury	En reclutamiento

Poland

Poland
Centro	Ciudad	Estado
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach	Katowice	En reclutamiento
Jagiellonian University Hospital	Krakow	En reclutamiento
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi	Lodz	Aún no recluta
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego	Lublin	En reclutamiento
Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan	En reclutamiento
Uniwersytecki Szpital Kliniczny nr 2 PUM	Szczecin	En reclutamiento
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	En reclutamiento
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu	Wroclaw	En reclutamiento
Silesian Center for Heart Diseases	Zabrze	En reclutamiento

Spain

Spain
Centro	Ciudad	Estado
Hospital Germans Trias i Pujol	Badalona	En reclutamiento
Hospital Clínico de Barcelona	Barcelona	En reclutamiento
La Paz University Hospital	Madrid	En reclutamiento
Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife	En reclutamiento

En el registro figuran 81 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

26 de agosto de 2026
Objetivo de inscripción modificado
Enrollment target revised down from 500 to 316
500316

Registro: ClinicalTrials.gov · NCT########

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