Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction

Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension, Systolic; Hypertension (HTN); Heart Failure With Preserved Ejection Fraction (HFpEF
• Intervention / Treatment: Device: Moderato Plus device with Cardiac Neuromodulation Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziv Belsky; Phone Number: 201-691-4240; Email: zbelsky@orchestrabiomed.com

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Tbilisi Heart and Vascular Clinic
  • Tbilisi, Georgia
    • Georgian Medical Research Clinic Healthycore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Clinical indication for dual-chamber pacemaker implantation or replacement
• Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction ≥50%
• History of hypertension
• NYHA functional class II or III
• On stable guideline-directed medical therapy
• Able and willing to provide written informed consent

Exclusion Criteria:

• NYHA class IV heart failure
• Permanent or persistent atrial fibrillation
• Recent acute decompensated heart failure
• Significant valvular heart disease requiring intervention
• Severe comorbid conditions that, in the investigator's judgment, would make study participation unsafe
• Pregnant or breastfeeding individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Neuromodulation Therapy; Participants receive the Moderato Plus device with Cardiac Neuromodulation Therapy	Device: Moderato Plus device with Cardiac Neuromodulation Therapy; Moderato Plus System with CNT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: BackBeat Medical Inc

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; HFpEF; CNT
• Additional Relevant MeSH Terms: Essential Hypertension; Vascular Diseases; Cardiovascular Diseases; Isolated Systolic Hypertension; Hypertension
• Other Study ID Numbers: CS-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No