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This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. The study will assess blood pressure and heart function at rest and during exercise, with and without CNT, for up to 12 months. Participants will receive the Moderato Plus device and complete scheduled follow-up visits. After study completion, CNT therapy will be discontinued and participants will return to standard medical care.
This study is a pilot, open-label, non-randomized feasibility investigation of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who are indicated for dual-chamber pacemaker implantation or replacement. The purpose of the study is to assess the feasibility of applying CNT and to evaluate its effects on blood pressure, heart failure status, and cardiac function at rest and during exercise over a follow-up period of up to 12 months. Eligible participants who provide informed consent and meet all inclusion and exclusion criteria will receive implantation of the Moderato Plus device. Following implantation, participants will complete scheduled study visits including two baseline visits and follow-up visits at approximately 3, 6, and 12 months. Study assessments may include blood pressure measurements, New York Heart Association (NYHA) functional class, echocardiographic evaluations, laboratory biomarkers, functional exercise testing, and patient-reported outcome questionnaires. At selected visits, cardiac performance during rest and standardized exercise conditions will be assessed to compare responses with CNT therapy activated and deactivated according to a predefined protocol. These comparisons are intended to evaluate short-term physiological responses to CNT and support feasibility assessments.
The first group of enrolled participants will undergo initial study assessments prior to long-term CNT activation to confirm the feasibility and appropriateness of the evaluation procedures. Based on this review, the study will continue as planned. Upon completion of the study follow-up, CNT therapy will be discontinued, and participants will resume standard clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Neuromodulation Therapy | Experimental | Participants receive the Moderato Plus device with Cardiac Neuromodulation Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderato Plus device with Cardiac Neuromodulation Therapy | Device | Moderato Plus System with CNT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Output During Supine Exercise | Cardiac output measured during supine rest and graded supine bicycle exercise using thermodilution techniques, with CNT activated and deactivated, at baseline and at 6 months. Results will be summarized as the change in cardiac output during exercise between baseline and follow-up. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-Hour Ambulatory Systolic Blood Pressure | Change in average 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit. | 3 months |
| Change in Daytime and Nighttime Ambulatory Systolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziv Belsky | Contact | 201-691-4240 | zbelsky@orchestrabiomed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgian Medical Research Clinic Healthycore | Tbilisi | Georgia | ||||
| Tbilisi Heart and Vascular Clinic |
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Change in average daytime and nighttime systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit. |
| 3-months |
| Change in Office Blood Pressure Measurements | Change in office-based systolic and diastolic blood pressure measurements at each study visit compared to baseline. | through study end, an average of 1 year |
| Change in NYHA Functional Class | Change in New York Heart Association (NYHA) functional classification assessed at Visits 4 (3 months) and 6 (12 months) compared with baseline. | at 3 months and 12 months |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score Overall Summary Score | Change in patient-reported health status as measured by the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Overall Summary Score, comparing follow-up assessments with baseline values. The KCCQ-23 is a validated, disease-specific instrument consisting of 23 items, with scores ranging from 0 to 100, where higher scores indicate better health status (fewer symptoms and physical and social limitations). | Baseline through study end, an average of 1 year |
| Change in Six-Minute Walk Distance | Change in functional exercise capacity as measured by the six-minute walk test, comparing follow-up assessments with baseline. | Baseline through study end |
| Change in NT-proBNP Levels | Change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels measured at follow-up compared with baseline. | Baseline through study end, an average of 1 year |
| Tbilisi |
| Georgia |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000092244 | Isolated Systolic Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000075222 | Essential Hypertension |
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