RECRUITING

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

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Conditions

HypertensionHypertension, SystolicHypertension, Essential

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Quick Facts

Study Start:2023-12-27
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06059638

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient has or is indicated for a de novo dual chamber pacemaker. Patient informed consent must be obtained within 30 days prior to a planned de novo implant of a Medtronic Astra/Azure dual chamber pacemaker system or up to 365 days after
  2. 2. On a stable antihypertension treatment regimen with 1, 2, or 3 classes of antihypertensive drugs
  3. 3. Office SBP ≥140 mmHg and \<180 mmHg
  4. 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
  1. 1. LVEF \<50%
  2. 2. NYHA Class II-IV
  3. 3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
  4. 4. Myocardial infarction (MI) within 3 months
  5. 5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
  6. 6. Persistent or permanent atrial fibrillation
  7. 7. Mitral valve regurgitation greater than grade 3
  8. 8. Aortic stenosis with a valve area less than 1.5 cm2
  9. 9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
  10. 10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Contacts and Locations

Study Contact

Hans-Peter Stoll, MD, PhD
CONTACT
646-956-2161
hpstoll@orchestrabiomed.com
Angela Stagg
CONTACT
astagg@orchestrabiomed.com

Principal Investigator

David Kandzari, MD
PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Andrea Russo, MD
PRINCIPAL_INVESTIGATOR
Cooper University

Study Locations (Sites)

HonorHealth
Scottsdale, Arizona, 85258
United States
Scripps Clinic
San Diego, California, 92121
United States
Citrus Cardiology Consultants
Crystal River, Florida, 34429
United States
Memorial Healthcare System
Hollywood, Florida, 33021
United States
Baptist Health Jacksonville
Jacksonville, Florida, 32207
United States
Baptist Health South Florida
Miami, Florida, 33176
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30309
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas, 67226
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
The Johns Hopkins University
Baltimore, Maryland, 21205
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University St. Louis
Saint Louis, Missouri, 63130
United States
The Cooper Health System
Camden, New Jersey, 08103
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Virtua Medical Group, P.A.
Marlton, New Jersey, 08053
United States
The Valley Hospital
Ridgewood, New Jersey, 07450
United States
Northwell Health, Inc.
New Hyde Park, New York, 11042
United States
The Lindner Research Center
Cincinnati, Ohio, 45219
United States
The Ohio State University
Columbus, Ohio, 43210
United States
OhioHealth Corporation
Columbus, Ohio, 43214
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73019
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, 38138
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204
United States

Collaborators and Investigators

Sponsor: Orchestra BioMed, Inc

  • David Kandzari, MD, PRINCIPAL_INVESTIGATOR, Piedmont Heart Institute
  • Andrea Russo, MD, PRINCIPAL_INVESTIGATOR, Cooper University

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 Registration Dates

Study Start Date2023-12-27
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-12-27
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertension
  • Hypertension, Systolic
  • Hypertension, Essential