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NCT06059638 · ClinicalTrials.gov registry record · NA
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
A NA study of Hypertension and Hypertension,Essential, sponsored by Orchestra BioMed.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06059638: Recruiting NA study of Hypertension and Hypertension,Essential, sponsored by Orchestra BioMed.
NCT06059638 is a NA study of Hypertension and Hypertension,Essential that is actively recruiting participants, run by Orchestra BioMed. The registered enrollment target is 500 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06059638, a NA study of Hypertension and Hypertension,Essential, is actively recruiting participants, sponsored by Orchestra BioMed.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Conditions Studied
Interventions
- DEVICE Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
- DEVICE Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Study Locations (20)
Florida
- HCA Florida JFK Hospital - Atlantis
- Cardiovascular Research Solutions (MyCardiologist) - Celebration
- Clearwater Cardiovascular Consultants - Clearwater
- Citrus Cardiology Consultants - Crystal River
- The Cardiac and Vascular Institute - Gainesville
- Memorial Healthcare System - Hollywood
- Baptist Health Jacksonville - Jacksonville
- Baptist Health South Florida - Miami
- Mount Sinai Medical Center of Florida - Miami Beach
- Sarasota Memorial Hospital - Sarasota
California
- Adventist Health Glendale - Glendale
- Stanford - Redwood City
- Scripps Clinic - San Diego
- Sutter Valley Hospitals - San Francisco
Colorado
- South Denver Cardiology - Denver
- Intermountain Health Lutheran Hospital - Golden
Georgia
- Piedmont Healthcare, Inc. - Atlanta
- Wellstar Research Institute - Marietta
Arizona
- HonorHealth - Scottsdale
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2029-08 |
| Phase | NA |
What NCT06059638 shows while recruiting
NCT06059638 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated is the first listed.
NCT06059638 names 20 study sites across 6 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06059638 about?
NCT06059638 is a clinical study titled "BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT". 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.
What is the current status of trial NCT06059638?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2023-12-27. Estimated completion is 2029-08.
What conditions does trial NCT06059638 study?
This clinical trial studies the following conditions: Hypertension, Hypertension,Essential, Hypertension, Systolic.
What interventions are being tested in trial NCT06059638?
The interventions under investigation include: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated (DEVICE), Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated (DEVICE).
Who is sponsoring clinical trial NCT06059638?
This trial is sponsored by Orchestra BioMed, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06059638 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06059638's enrollment target sits among peer trials
500 116th of 470 higher than 349 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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