Study on a new pacemaker software (atrioventricular interval modulation = AVIM) to control high blood pressure (BACKBEAT study)
Zusammenfassung der Studie
This is a multinational, randomized, double-blind study aimed at assessing the safety and efficacy of AVIM treatment in patients with uncontrolled hypertension and who have a previously implanted Medtronic Astra/Azure pacemaker. More than 500 participants will be recruited at 100 centers in the United Kingdom, Europe, Switzerland, and the United States. In this trial, the experimental device "Medtronic pacemaker with AVIM treatment" will be evaluated. If you already have a Medtronic Astra/Azure pacemaker and agree to participate in this trial, an AVIM treatment will be installed, which will modify the rhythm of the pacemaker to treat your hypertension. Additionally, you will continue to take your prescribed medications for hypertension as usual. Participation in this trial is expected to last a maximum of 37 months. During the first year of participation, the AVIM treatment may be activated or deactivated in your pacemaker. You will have an equal chance of being included in either group. This will help determine the effects of this therapy within the context of this research. This 12-month period is referred to as the "blinded" study phase. This means that neither you, nor the study doctors, nor the research staff and nurses involved in the study will know whether the AVIM treatment is activated or deactivated during these 12 months. In case of emergency only, the blindness will be lifted for individuals with access to this information. After 12 months, you may switch groups. If you were in the "deactivated" group, you could move to the "activated" group and receive the AVIM treatment for the remainder of your participation in the trial. Once the trial is completed, the AVIM treatment will be removed from your pacemaker. From that point on, your pacemaker will function as usual, without using the AVIM treatment.
(BASEC)
Untersuchte Intervention
A new therapeutic option, called "atrioventricular interval modulation" (AVIM) treatment, is currently being studied to treat uncontrolled hypertension in patients with a pacemaker. Orchestra BioMed, the sponsor of the study, is partnering with Medtronic to offer this treatment to patients by conducting a large global clinical trial. This technology, which has been examined in other studies, is made possible by a temporary modification of the pacemaker software, which can be performed during a routine check of your device.
(BASEC)
Untersuchte Krankheit(en)
It is estimated that over 70% of patients with a pacemaker have high blood pressure, also known as hypertension. Although it rarely causes symptoms, hypertension is a serious condition and is one of the leading factors contributing to cardiovascular diseases and mortality worldwide. Although medications are often effective in controlling blood pressure, over 40% of hypertensive patients continue to have blood pressure that is too high.
(BASEC)
• Within 90 days of de novo implantation of a Medtronic Astra/Azure dual-chamber pacemaker and Medtronic stimulation electrodes. • Under stable antihypertensive treatment (without changes in the 4 weeks prior to consent) with 1, 2, or 3 classes of antihypertensive medications, which will be maintained without changes for a period of at least 4 months. • Systolic blood pressure ≥ 140 mmHg and < 180 mmHg. (BASEC)
Ausschlusskriterien
• Persistent or permanent atrial fibrillation that would prevent or limit the administration of AVIM treatment • Left ventricular ejection fraction (LVEF) < 50% (according to center assessment) • Aortic stenosis with an aortic valve opening area of less than 1.5 cm² (according to center assessment) (BASEC)
Studienstandort
Basel, Bern, Lugano
(BASEC)
Sponsor
Orchestra Biomed, Inc. FGK Representative Service AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Yuval Mika
+1 8569123155
ymika@clutterorchestrabiomed.comOrchestra Biomed, Inc.
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.10.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Stimulateur cardiaque pour bradycardie avec modulation du délai AV pour le traitement de l’hypertension artérielle (étude BACKBEAT) (BASEC)
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