BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

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.

Conditions

Hypertension, Hypertension, Systolic, Hypertension, Essential

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Study Overview

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Study Details

Study overview

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.

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth, Scottsdale, Arizona, United States, 85258

San Diego

Scripps Clinic, San Diego, California, United States, 92121

Crystal River

Citrus Cardiology Consultants, Crystal River, Florida, United States, 34429

Hollywood

Memorial Healthcare System, Hollywood, Florida, United States, 33021

Jacksonville

Baptist Health Jacksonville, Jacksonville, Florida, United States, 32207

Miami

Baptist Health South Florida, Miami, Florida, United States, 33176

Sarasota

Sarasota Memorial Hospital, Sarasota, Florida, United States, 34239

Atlanta

Piedmont Healthcare, Inc., Atlanta, Georgia, United States, 30309

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Wichita

West Houston Area Clinical Trial Consultants (Wichita, KS), Wichita, Kansas, United States, 67226

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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. 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
  • 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 grade 3
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Orchestra BioMed, Inc,

David Kandzari, MD, PRINCIPAL_INVESTIGATOR, Piedmont Heart Institute

Andrea Russo, MD, PRINCIPAL_INVESTIGATOR, Cooper University

Study Record Dates

2028-06