BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT (BACKBEAT)
Sponsor: Medtronic
A observational or N/A phase clinical study on Hypertension and Hypertension, Essential, this trial is actively recruiting participants. The trial is conducted by Medtronic and has accumulated 22 data snapshots since 2023. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.
Study Description(click to expand)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.
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.
Status Flow
Change History
22 versions recorded-
Apr 18, 2026 — Present [daily]
Recruiting
Phase: NA → None
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Jan 2026 — Apr 2026 [monthly]
Recruiting NA
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Dec 2025 — Jan 2026 [monthly]
Recruiting NA
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Oct 2025 — Dec 2025 [monthly]
Recruiting NA
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Sep 2025 — Oct 2025 [monthly]
Recruiting NA
▶ Show 17 earlier versions
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Aug 2025 — Sep 2025 [monthly]
Recruiting NA
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Jul 2025 — Aug 2025 [monthly]
Recruiting NA
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Jun 2025 — Jul 2025 [monthly]
Recruiting NA
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Apr 2025 — Jun 2025 [monthly]
Recruiting NA
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Mar 2025 — Apr 2025 [monthly]
Recruiting NA
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Jan 2025 — Mar 2025 [monthly]
Recruiting NA
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Dec 2024 — Jan 2025 [monthly]
Recruiting NA
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Oct 2024 — Dec 2024 [monthly]
Recruiting NA
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Sep 2024 — Oct 2024 [monthly]
Recruiting NA
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Aug 2024 — Sep 2024 [monthly]
Recruiting NA
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Jul 2024 — Aug 2024 [monthly]
Recruiting NA
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Jun 2024 — Jul 2024 [monthly]
Recruiting NA
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Apr 2024 — Jun 2024 [monthly]
Recruiting NA
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Mar 2024 — Apr 2024 [monthly]
Recruiting NA
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Feb 2024 — Mar 2024 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
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Dec 2023 — Feb 2024 [monthly]
Not Yet Recruiting NA
Status: Withheld → Not Yet Recruiting · Phase: None → NA
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Oct 2023 — Dec 2023 [monthly]
Withheld
First recorded
Eligibility Summary
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.
Contact Information
- Medtronic
- Orchestra BioMed, Inc
For direct contact, visit the study record on ClinicalTrials.gov .