BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT (BACKBEAT)

March 25, 2024 updated by: Orchestra BioMed, Inc
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in three phases: 1) Screening/ Run-in Phase, 2) Double-blind Randomized phase (1 year), and 3) Randomized unblinded phase (2 years). Patients within 90 days of de novo implant of a Medtronic Astra/Azure pacemaker also having uncontrolled hypertension may be approached for inclusion into this study. During the Double-blind Randomized Phase, subjects in the control group will receive standard-of-care pacemaker and hypertension therapy.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia
        • Recruiting
        • Na Homolce Hospital
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Semmelweis University
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth
    • Florida
      • Crystal River, Florida, United States, 34429
        • Recruiting
        • Citrus Cardiology Consultants
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • West Houston Area Clinical Trial Consultants (Wichita, KS)
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Medical Group, P.A.
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Valley Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Lindner Research Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Within 90 days of a de novo implant of a Medtronic Astra/Azure dual chamber pacemaker and Medtronic pacing leads
  2. On a stable antihypertension treatment regimen with 1, 2 or 3 classes of antihypertensive drugs
  3. Office SBP ≥140 mmHg and <180 mmHg
  4. Average 24-Hour aSBP ≥130 mmHg and <170 mmHg

Exclusion Criteria:

  1. LVEF <50%
  2. NYHA Class II-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. Persistent or permanent atrial fibrillation
  7. Mitral valve regurgitation greater than 2+
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
AVIM therapy activated with continued stable antihypertensive drug therapy
Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
Other Names:
  • BackBeat CNT
Sham Comparator: Control Group
AVIM therapy deactivated with continued stable antihypertensive drug therapy
Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
Time Frame: Baseline and 3 months post randomization
Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Baseline and 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
Time Frame: 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
3 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orchestra BioMed, Inc

Collaborators

Medtronic

Investigators

  • Principal Investigator: David Kandzari, MD, Piedmont Heart Institute
  • Principal Investigator: Andrea Russo, MD, Cooper University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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