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Cardiac Neuromodulation Therapy (CNT) "Washout" Sub-Study

NCT05086523 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-11-03

No results posted yet for this study

Summary

This washout protocol is structured as a sub-study for patients willing to participate after finishing the double blind randomised phase of the clinical trial, NCT02837445. Devices will be turned off for a week approximately. Patients will have their PHC programmed to automatically turn off 24 hr after a medical and technical visit and remain in regular pacing. Ambulatory recording of the BP will start at the end of the visit, and continue for 24 hr after the turn off time (48 hr recording). Conversely, patients will return at the end of the first week, when a second 48 hr recording will be initiated, this time, the PHC will be programmed to turn on 24 hr later. The recordings therefore will provide data of the ON to OFF transition for the evaluation of the residual effect of PHC after 24 h and after week.

Conditions

  • Hypertension,Essential
  • Systolic Hypertension

Interventions

DEVICE

Programmable Hypertension Control (BackBeat Moderato)

Programmable Hypertension Control can be turned OFF without affecting regular pacing

DEVICE

Pacing (BackBeat Moderato)

Programmable Hypertension Control can be turned OFF without affecting regular pacing

Sponsors & Collaborators

  • BackBeat Medical Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2023-08-31
Completion
2023-09-30

Countries

  • Czechia
  • Hungary
  • Poland

Study Locations

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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 NCT05086523 on ClinicalTrials.gov