Novel Setup Algorithm for Cardiac Neuromodulation Therapy

NCT05719454 | Recruiting DMC

• 1 other identifier: CS-10 BBM NOV SA
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 7

Brief 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

Hypertension; Bradycardia

Outcome Measures

Primary Outcomes (2)

• CNT efficacy: Changes in average 24 hour systolic ambulatory blood pressure

  The change in the 24 hr blood pressure recording after each of the two set up sessions (week 4 and week 6) will be compared to the 24 hr ambulatory data of the control (week 3).

  up to 12 Month follow-up visit

• CNT safety: Incidence of device- and treatment-related adverse and serious adverse

  Incidence of device- and treatment-related adverse and serious adverse events during the study.

  up to 12 Month follow-up visit

Study Arms (3)

CNT Setup Algorithm Version 1

EXPERIMENTAL

When performing the Setup Algorithm Version 1, each subject's blood pressure is measured with a standard cuff system while the BackBeat-CNT is activated, and system parameters are varied successively according to a specified sequence or based on the blood pressure measurements obtained during previous activations of BackBeat CNT, until the Setup Algorithm is complete. The parameter values as determined by the Setup Algorithm will constitute the programming of the Moderato IPG for the 24 hour activation following setup.

Device: CNT testing

CNT Setup Algorithm Version 2

EXPERIMENTAL

When performing the Setup Algorithm Version 1, each subject's blood pressure is measured with a standard cuff system while the BackBeat-CNT is activated, and system parameters are varied successively according to a specified sequence or based on the blood pressure measurements obtained during previous activations of BackBeat CNT, until the Setup Algorithm is complete. The parameter values as determined by the Setup Algorithm will constitute the programming of the Moderato IPG for the 24 hour activation following setup.

Device: CNT testing

CNT therapy optimization without use of the Setup Algorithm

OTHER

For this optimization procedure, each subject's blood pressure is measured with a continuous blood pressure measurement system while the BackBeat-CNT is activated, and system parameters are varied according to a specified sequence until the desired blood pressure reduction is achieved. The parameter values that provide the desired blood pressure reduction will be recorded, for possible use by the investigator following trial completion

Device: CNT testing

Interventions

CNT testing DEVICE

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

CNT Setup Algorithm Version 1; CNT Setup Algorithm Version 2; CNT therapy optimization without use of the Setup Algorithm

Eligibility Criteria

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

You may qualify if:

• Subject is ≥ 18 years of age
• Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker.
• Subject has stable (for prior 1 month) hypertension treatment with 1, 2 or 3 antihypertensive drugs, which is planned to be maintained without changes for a period of at least 2 months post implant.
• Subject has an office systolic blood pressure (oSBP) ≥140 and \<180 mmHg
• At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and \<170 mmHg and an office blood pressure (oSBP) ≥140 and \<180 mmHg.
• Subject is willing and able to comply with study visits and procedures
• Subject is willing to adhere to the prescribed baseline antihypertension medical regimen for the duration of the study.

You may not qualify if:

• \. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma)
• Subject has permanent atrial fibrillation
• Subject has intermittent paroxysmal atrial fibrillation/flutter with significant burden (i.e., \>10% atrial fibrillation/flutter beats if available.
• Subject has an ejection fraction \<50%
• Subject has a drop of \> 15% (absolute) in ejection fraction from baseline to week 4
• Subject has symptoms of heart failure, NYHA Class II or greater
• Subject has mitral regurgitation ≥2+, aortic stenosis with valve area \<1.0 cm2 , or is expected to need a valve repair or replacement.
• Subject has a history of stroke or TIA within 12 months or any prior stroke with a residual neurological deficit (modified Rankin Score \>2+)
• Subject experienced myocardial infarction (MI) within 3 months prior to enrolment
• Subject had a cardiovascular interventional procedure or cardiovascular surgery within 6 months prior to enrolment
• Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
• Subject is on dialysis
• Subject has estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m²
• Subject has significant (\>50% occlusion of left or right carotid artery) carotid artery stenosis
• Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden cardiac arrest

Sponsors & Collaborators

• BackBeat Medical Inc: lead

Study Sites (7)

Nemocnice Na Homolce (Na Homolce Hospital)

Prague, 15030, Czechia

NOT YET RECRUITING

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

RECRUITING

Jagiellonian University Hospital

Krakow, 30-688, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 61-848, Poland

NOT YET RECRUITING

Samodzielny Pub. Szpital Kliniczny nr 2 PUM

Szczecin, 72 70-111, Poland

NOT YET RECRUITING

Publiczny Centralny Szpital

Warsaw, 02-097, Poland

NOT YET RECRUITING

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension; Bradycardia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Béla MERKELY, Prof. MD

  Semmelweis University Heart and Vascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Korthout

CONTACT

+41783482383; lkorthout@orchestrabiomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will undergo in visits 4 and 5 two sessions to test two different setup CNT Algorithms. One version will favor atrial pacing. The order of the setup versions will alternate, whereby subjects will start with setup version 1 or setup version 2 Subjects will be sequentially assigned to Version 1 or 2 on alternating basis: first subject to Version 1, second to Version 2, third to Version 1, etc. hey will also undergo setup without the use of an algorithm, similar to the method used in the MODERATO II study.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 9, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

HU (1); CZ (1); PL (5)