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Novel Setup Algorithm for Cardiac Neuromodulation Therapy

NCT05719454 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-09

No results posted yet for this study

Summary

After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume.

The ambulatory data will provide the basis for a lasting CNT programming by week 8. Follow up visits will be scheduled after 3, 6, and 12 months.

Conditions

Interventions

DEVICE

CNT testing

The effect of CNT on blood pressure will be obtained throughout the year long follow up period.

Sponsors & Collaborators

  • BackBeat Medical Inc

    lead INDUSTRY

Principal Investigators

  • Béla MERKELY, Prof. MD · Semmelweis University Heart and Vascular Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2027-01-31
Completion
2028-02-28

Countries

  • Czechia
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05719454 on ClinicalTrials.gov