BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Overview

About this study

The purpose of this study is to evaluate 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/28/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Siva Mulpuru, M.D., M.P.H.	Contact us for the latest status	Contact information: CVRU Heart Rhythm Services Research Team (507) 255-0774

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Siva Mulpuru, M.D., M.P.H.

Contact us for the latest status

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double-blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual-chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1-month run-in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between-group difference of the change in 24-hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, -15.2 to -8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (-7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (-14.2 to -1.9 mm Hg) (=0.012). There were no Moderato device- or CNT-related adverse events. Conclusions CNT significantly reduced 24-hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02837445. Read More on PubMed

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