NCT05345925

Brief Summary

In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. CNT effects on BP will be evaluated with a PV conductance catheter in the LV, and with optional BP catheters in the aorta and/or RV. CNT will be delivered by externally by the BackBeat Moderato System IPG. Abbreviations: CNT, Cardiac Neuromodulation Therapy; IPG, Implanted Pulse Generator; ICD, Implanted Cardiac Defribillator; CRT-P or D, Cardiac Resynchronisation Therapy-Pacemaker or Defibrillator; RV, Right Ventricle; LV, Left Ventricle; BP, Blood Pressure

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

April 8, 2022

Last Update Submit

April 26, 2023

Conditions

BradycardiaA-V Block

Outcome Measures

Primary Outcomes (1)

  • Average changes in Systolic Blood Pressure Change

    When compared to standard pacing, CNT elicits a reduction in Systolic Blood Pressure (mmHg)

    through study completion (18 months)

Secondary Outcomes (5)

  • Average Cardiac Volumes (End Diastolic and End Systolic volumes, stroke volumes)

    through study completion (18 months)

  • Average Ejection Fraction (the percent of blood volume ejected per beat)

    through study completion (18 months)

  • Average Cardiac Pressures (End Systolic and Diastolic Pressures)

    through study completion (18 months)

  • Average cardiac contractility

    through study completion (18 months)

  • Average Systemic Vascular Resistance

    through study completion (18 months)

Study Arms (1)

Experimental group

EXPERIMENTAL

Eligible subjects instrumented for CNT testing

Device: Moderato

Interventions

ModeratoDEVICE

Several algorithms comprising CNT will be delivered by the Moderato Implantable Pulse Generator. Each application will last approximately 3 min with 2 minutes baseline (regular pacing) between them. Hence, each subject will serve as its own control (during pacing) and test (during CNT application). Furthermore, the average control value for the whole group will be compared with the average test values of CNT algorithms at the different ventricular lead locations for efficacy assessments. Stratification of subjects by initial hemodynamic parameters (such as Ejection Fraction, for example) would be possible depending on the total number of subjects in each group.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is ≥ 18 years of age.
  • Subject is indicated for an implant or a replacement with a planned upgrade of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D).
  • Subject is willing and able to comply with the study procedures.

You may not qualify if:

  • Subject is dependent on 100% ventricular pacing.
  • Subject has symptoms of heart failure, NYHA Class III or greater
  • Subject has an ejection fraction of 25% or less
  • Subject's systolic blood pressure is less than 100 mmHg on the day of implant
  • Subject has decompensated heart failure
  • Subject has significant (\>2+) valvular regurgitation or any valvular stenosis.
  • Subject has permanent atrial fibrillation
  • Subject has atrial fibrillation on the day of the study.
  • Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy, or interventricular septal thickness ≥15 mm
  • Subject is on dialysis
  • Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke) at any prior time that has resulted in residual neurologic deficit.
  • Subject has a history of autonomic dysfunction
  • Patient cannot receive heparin for any reason (such as a history of Heparin induced thrombocytopenia (HIT))
  • Women who are pregnant or breast-feeding
  • Subject cannot or is unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Jagiellonian University

Krakow, 30-688, Poland

Location

Related Publications (4)

  • Klotz S, Dickstein ML, Burkhoff D. A computational method of prediction of the end-diastolic pressure-volume relationship by single beat. Nat Protoc. 2007;2(9):2152-8. doi: 10.1038/nprot.2007.270.

    PMID: 17853871BACKGROUND

  • Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974.

    PMID: 29275370RESULT

  • Yang B, Wang Y, Zhang F, Ju W, Chen H, Mika Y, Aviv R, Evans SJ, Burkhoff D, Wang J, Chen M. Rationale and evidence for the development of a durable device-based cardiac neuromodulation therapy for hypertension. J Am Soc Hypertens. 2018 May;12(5):381-391. doi: 10.1016/j.jash.2018.03.004. Epub 2018 Mar 21.

    PMID: 29628351RESULT

  • Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13.

    PMID: 34387126RESULT

MeSH Terms

Conditions

BradycardiaAtrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Study Officials

  • Marek Jastrzębski,, MD, PhD

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Mika, Ph.D.

CONTACT

+18569123155ymika@orchestrabiomed.com

Norbert Rosenthal, B.Sc.

CONTACT

+491792482543nrosenthal@orchestrabiomed.com

Study Design

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

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 26, 2022

Study Start

May 2, 2023

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)