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Completed NCT05086523

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

Conditions: Hypertension,Essential, Systolic Hypertension

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 28
Sponsor: BackBeat Medical Inc

Location: Na Homolce Hospital Prague

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.

Eligibility Criteria

Inclusion Criteria: * Subject is implanted with a Moderato® implantable pulse generator (IPG) and is being followed by the site per standard of care. * Subject has an average office systolic blood pressure \> 130 mmHg and \< 170 mmHg at the sub-study screening visit. Exclusion Criteria: * Subject has permanent atrial fibrillation. * Subject had significant paroxysmal atrial fibrillation/flutter burden (defined as \>25% of beats) in the past month. Atrial fibrillation/flutter burden will be determined by interrogation of the Moderato pulse generator. * Subject experienced neurological events (stroke or TIA) within the past year. Subject have had a serious adverse event classified as related to CNT or the Backbeat Moderato device. * Female subject who is pregnant, breast-feeding, intends to become pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use contraception during the study. * Subject cannot or is unwilling to provide informed consent.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05086523). StuddyBuddy aggregates publicly available trial information.