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

NCT07598760 | Not Yet Recruiting

• 1 other identifier: CS-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension (HTN); Heart Failure With Preserved Ejection Fraction (HFpEF; Hypertension, Systolic

Keywords

CNT; HFpEF; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in 24-Hour Ambulatory Systolic Blood Pressure

  3 months

• Change in Daytime and Nighttime Ambulatory Systolic Blood Pressure

  3-months

• Change in Office Blood Pressure Measurements

  through study end, an average of 1 year

• Change in NYHA Functional Class

  at 3 months and 12 months

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score Overall Summary Score

  Baseline through study end, an average of 1 year

Study Arms (1)

Cardiac Neuromodulation Therapy

EXPERIMENTAL

Participants receive the Moderato Plus device with Cardiac Neuromodulation Therapy

Device: Moderato Plus device with Cardiac Neuromodulation Therapy

Interventions

Moderato Plus device with Cardiac Neuromodulation Therapy DEVICE

Moderato Plus System with CNT

Cardiac Neuromodulation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BackBeat Medical Inc: lead

Study Sites (2)

Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Hypertension; Isolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Essential Hypertension

Central Study Contacts

Ziv Belsky

CONTACT

201-691-4240; zbelsky@orchestrabiomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

GE (2)