BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

ID#: NCT06059638

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: December 27, 2023

End Date: August 01, 2029

Contact Information:
Hans-Peter Stoll, MD, PhD
646-956-2161
Angela Stagg
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.
Eligibility:

Inclusion Criteria:

1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamber pacemaker system or at any time thereafter

2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug

3. Office SBP ≥135 mmHg and <180 mmHg

4. Average 24-Hour aSBP ≥130 mmHg and <170 mmHg

Exclusion Criteria:

1. LVEF <50%

2. NYHA Class III-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. Permanent atrial fibrillation

7. Mitral valve regurgitation greater than or equal to 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
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