Pacemaker Programming for Hypertension Clinical Trial in Oklahoma City

Living With High Blood Pressure and a Pacemaker?

You may qualify for a hypertension clinical trial at Hightower.

High blood pressure (hypertension) affects millions of adults across the U.S. and remains one of the leading causes of heart disease, stroke, and kidney failure. Despite the availability of multiple medications, many individuals struggle to keep their blood pressure under control.

Hightower Clinical is enrolling participants for an innovative research study exploring a bioelectronic therapy that could help manage essential hypertension (high blood pressure with no identifiable medical cause) in people who already have, or are receiving, a dual-chamber pacemaker.

*Participation in the Clinical Trial is completely free of cost and is your choice.

*To participate, fill out the form, and someone from our research staff will call you to determine your eligibility for the Clinical Research Study.

About the BACKBEAT Hypertension Clinical Trial

The BACKBEAT Study is a hypertension clinical trial designed to evaluate a new, non-drug therapy called AV Interval Modulation (AVIM) for adults with essential or systolic hypertension who have a dual-chamber pacemaker. This therapy uses an FDA-approved Medtronic pacemaker programmed to slightly adjust the timing between the heart’s upper and lower chambers, which may naturally lower blood pressure and improve heart function.

The study aims to determine whether this pacing-based therapy can significantly reduce 24-hour systolic blood pressure compared to standard pacemaker settings. In partnership with Orchestra BioMed, Hightower Clinical is helping advance innovative, device-based approaches to improve outcomes for patients whose blood pressure remains uncontrolled despite medication.

*All study procedures and study-related treatment, including the investigational drug, are free of cost, and insurance is not required to participate.

*The study doctor will take you through every step of the Clinical Trial before you decide to participate and will answer any questions you have about the study treatment.

Hypertension Research: What to Expect?

Upon agreeing to participate, you’ll be asked to sign an Informed Consent Form that explains all study details, potential risks, and your rights as a participant. Our clinical research team will guide you through every step of the process, answer your questions, and ensure you feel comfortable before enrollment.

Once consent is provided, participants will go through a screening and stabilization phase, during which your blood pressure and medications will be monitored to confirm eligibility.

After that, participants are randomly assigned to one of two groups, either receiving the investigational therapy (AVIM ON) or standard pacing therapy (AVIM OFF). This study uses a double-blind design, meaning neither you nor the study team will know which therapy you’re receiving to ensure unbiased results.

Throughout the study, participants will attend regular visits where blood pressure levels, heart rate, and pacemaker settings are closely monitored. You’ll also receive guidance on maintaining your current medications and lifestyle while participating in the hypertension clinical trial.

* Study-related care is offered at no charge. Expert physicians and healthcare professionals conduct thorough physical exams and assessments.