Cardiac Neuromodulation for Heart Failure
BackBeat Medical Cardiac Neuromodulation Therapy in Patients With Heart Failure: An Acute Feasibility Study
1 other identifier
observational
11
1 country
1
Brief Summary
This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2020
Typical duration for all trials
1 active site
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
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedJuly 18, 2022
July 1, 2022
2.1 years
September 28, 2020
July 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Arterial Elastance
Arterial elastance is reduced when sympathetic activity is reduced, an indication of a relaxed peripheral resistance.
Immediate, derived form ongoing Pressure Volume changes in the Left ventricle
Interventions
A modified CNT, will be delivered as a pacing sequence able to acutely influence sympathetic tone.
Eligibility Criteria
These are Heart Failure subjects willing to participate in a short acute clinical study during the implantation or replacement of a single chamber ICD.
You may qualify if:
- Subject is ≥ 18 years of age
- Subject has a primary indication and is scheduled for ICD implantation or replacement
- Subject has heart failure NYHA Class II or III
You may not qualify if:
- Subject is to receive a single chamber defibrillator
- Subject has an ejection fraction of 25% or less
- Subject's systolic blood pressure is less than 120 mm Hg on the day of implant
- Subject has decompensated heart failure
- Subject has significant (\>2+) mitral regurgitation, aortic regurgitation or aortic 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 has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) at any prior time that has resulted in residual neurologic deficit.
- Subject has a history of autonomic dysfunction
- 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
- BackBeat Medical Inclead
- CD Leycomcollaborator
Study Sites (1)
Silesian Center for Heart Diseases
Zabrze, 41-800, Poland
Related Publications (3)
Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur J Heart Fail. 2008 Oct;10(10):933-89. doi: 10.1016/j.ejheart.2008.08.005. Epub 2008 Sep 16. No abstract available.
PMID: 18826876BACKGROUNDRoger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.
PMID: 22215894BACKGROUNDvan Bilsen M, Patel HC, Bauersachs J, Bohm M, Borggrefe M, Brutsaert D, Coats AJS, de Boer RA, de Keulenaer GW, Filippatos GS, Floras J, Grassi G, Jankowska EA, Kornet L, Lunde IG, Maack C, Mahfoud F, Pollesello P, Ponikowski P, Ruschitzka F, Sabbah HN, Schultz HD, Seferovic P, Slart RHJA, Taggart P, Tocchetti CG, Van Laake LW, Zannad F, Heymans S, Lyon AR. The autonomic nervous system as a therapeutic target in heart failure: a scientific position statement from the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2017 Nov;19(11):1361-1378. doi: 10.1002/ejhf.921. Epub 2017 Sep 26.
PMID: 28949064BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Zbigniew Kalarus, Prof. MD Ph.D
Silesian Center for Heart Diseases
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 5, 2020
Study Start
December 15, 2020
Primary Completion
January 31, 2023
Study Completion
May 30, 2023
Last Updated
July 18, 2022
Record last verified: 2022-07