NCT06059638ClinicalTrials.gov

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

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.

Interventistico316 partecipanti ricercati131 centri15 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

ClinicalTrials.govNCT06059638Apri questa scheda su ClinicalTrials.govSincronizzato 4 settimane fa

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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.

Sintesi

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.

Patologie

Hypertension
Hypertension, Systolic
Hypertension, Essential

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Non applicabile
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	TRIPLE (3)
Arruolamento	316 partecipanti ricercati

Sponsor e collaboratori

Orchestra BioMed, Inc Sponsor
Medtronic Collaboratori

Bracci e interventi

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

Interventi

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

Esiti misurati

Esito primario
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
Orizzonte temporale Baseline and 3 months post randomization
Esito primario
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
Orizzonte temporale 3 months post randomization

Date

Date
Data di inizio	27 dicembre 2023 (effettiva)
Conclusione primaria	1 dicembre 2026 (stimata)
Conclusione	1 agosto 2029 (stimata)
Prima pubblicazione	28 settembre 2023 (effettiva)
Ultimo aggiornamento	26 agosto 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	agosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

111 centri stanno reclutando

Australia

Australia
Struttura	Città	Stato o regione	Stato
Lyell McEwin Hospital	Elizabeth Vale	South Australia	In reclutamento

Belgium

Belgium
Struttura	Città	Stato
OLV Ziekenhuis	Aalst	Ritirato
Middelheim Ziekenhuis	Antwerp	In reclutamento
Universite Libre de Bruxelles-Erasme Hospital	Brussels	In reclutamento
UZ Brussel	Brussels	Ritirato
UZ Leuven	Leuven	In reclutamento

China

China
Struttura	Città	Stato o regione	Stato
Jiangsu Province Hospital	Nanjing		In reclutamento
Nanjing Drum Tower Hospital	Nanjing	Jiangsu	In reclutamento

Czechia

Czechia
Struttura	Città	Stato
Institute for Clinical and Experimental Medicine (IKEM)	Prague	In reclutamento
Fakultní nemocnice Královské Vinohrady (FNKV)	Prague	In reclutamento
Na Homolce Hospital	Prague	In reclutamento

France

France
Struttura	Città	Stato
CHU Grenoble	Grenoble	In reclutamento
Hospices Civils de Lyon (HCL)	Lyon	In reclutamento
CHU de Nantes	Nantes	In reclutamento
AP-HP Hôpital Pitié Salpêtrière	Paris	In reclutamento
CHRU Tours	Tours	In reclutamento

Germany

Germany
Struttura	Città	Stato
Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)	Berlin	In reclutamento
Herzzentrum Bonn am Universitätsklinikum Bonn	Bonn	In reclutamento
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus	Frankfurt	In reclutamento
Universitätsklinikum Hamburg-Eppendorf	Hamburg	In reclutamento
Herzzentrum Leipzig	Leipzig	Non ancora in reclutamento
University Hospital Luebeck	Lübeck	In reclutamento
University Medical Centre Mannheim	Mannheim	In reclutamento
Saarland University Hospital	Saarbrücken	In reclutamento
Krankenhaus der Barmherzigen Brüder Trier	Trier	In reclutamento

Hungary

Hungary
Struttura	Città	Stato
Central Hospital of Northern Pest - Military Hospital	Budapest	In reclutamento
Semmelweis University	Budapest	In reclutamento
University of Debrecen	Debrecen	In reclutamento
University of Szeged	Szeged	In reclutamento

Italy

Italy
Struttura	Città	Stato
Policlinico Di Sant Orsola Malpighi	Bologna	In reclutamento
Campus Bio-Medico University Hospital	Rome	In reclutamento
Azienda Ospedaliera Universitaria Integrata Verona	Verona	In reclutamento
IRCCS Sacro Cuore Don Calabria	Verona	In reclutamento

Netherlands

Netherlands
Struttura	Città	Stato
Amsterdam University Medical Centre	Amsterdam	In reclutamento
Maastricht UMC+	Maastricht	In reclutamento
Isala Klinieken	Zwolle	In reclutamento

New Zealand

New Zealand
Struttura	Città	Stato o regione	Stato
ChristChurch Hospital	Christchurch	Canterbury	In reclutamento

Poland

Poland
Struttura	Città	Stato
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach	Katowice	In reclutamento
Jagiellonian University Hospital	Krakow	In reclutamento
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi	Lodz	Non ancora in reclutamento
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego	Lublin	In reclutamento
Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan	In reclutamento
Uniwersytecki Szpital Kliniczny nr 2 PUM	Szczecin	In reclutamento
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	In reclutamento
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu	Wroclaw	In reclutamento
Silesian Center for Heart Diseases	Zabrze	In reclutamento

Spain

Spain
Struttura	Città	Stato
Hospital Germans Trias i Pujol	Badalona	In reclutamento
Hospital Clínico de Barcelona	Barcelona	In reclutamento
La Paz University Hospital	Madrid	In reclutamento
Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife	In reclutamento

Nella scheda del registro sono indicati altri 81 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

26 agosto 2026
Obiettivo di arruolamento modificato
Enrollment target revised down from 500 to 316
500316

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

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