Investigator-Initiated Research

Investigator-Initiated Research

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What is Investigator Initiated Research?
Investigator Initiated Research (IIR) studies are designed and conducted independently by investigators who also serve as the study sponsor. As the sponsor, the investigator assumes all responsibilities for complying with applicable regulatory requirements. IIR may be supported by LivaNova in the form of product, funding and/or technical input.

Key Areas of Interest for Investigator Initiated Research

Neuromodulation

(1) Studies that quantify the consequences of uncontrolled epilepsy/not adequately treating drug resistant epilepsy (DRE). Clinical, economic, and societal outcomes utilizing Patient Reported Outcome Measures (PROMs), Patient Reported Experience Measures (PREMs), as well as clinical and healthcare resource utilization data to quantify the consequences of not adequately treating DRE. Clinical outcomes including mortality, injury, comorbid conditions such as depression, changes in cognition, loss of function, and failure to achieve developmental milestones. Economic analyses including cost utility analyses, cost effectiveness analyses, cost consequence analyses, and budget impact models. Societal impact outcomes related to education, employment, and productivity.

Key interests include: Prospective comparison of outcomes in patients receiving late versus early intervention with VNS Therapy; Prospective comparative studies with combined clinical, economic, and societal outcomes; Evaluation of adherence to local guidelines for treatment of epilepsy and the correlation with clinical, economic, and societal outcomes.
 
(2) Studies that compare VNS Therapy with standard of care (SOC) and/or synergistic mechanisms with other forms of neuromodulation or next generation Anti-Seizure Drugs (ASDs). Clinical, economic, and societal outcomes utilizing Patient Reported Outcome Measures (PROMs), Patient Reported Experience Measures (PREMs) and/or clinical and healthcare resource utilization data to quantify and compare the efficacy, safety, compliance, and healthcare utilization for various treatment pathways for DRE.

Key interests include: Prospective comparison of outcomes in patients receiving VNS Therapy, RNS, DBS, or ASDs; Prospective comparative studies with combined clinical, economic, and societal outcomes; Clinical outcomes including changes in seizure frequency, seizure severity, cognition, and quality of life (both disease specific and generic health status measures such as EQ5D); Evaluation of potential synergistic mechanisms between VNS Therapy and other neuromodulation therapies and/or next generation anti-seizure drugs.

(3) Studies that evaluate the disease modification capability of VNS Therapy. Evaluation of novel biomarkers and/or signals of target engagement that correlate with clinical response to VNS Therapy in patients with Drug Resistant Epilepsy.

Key interests include: Prospective comparison of changes in functional connectivity (e.g. modification of the epileptic focus or epileptogenic networks), electrophysiological parameters, molecular biomarkers (e.g. cytokines), or others.
 
Advanced Circulatory Support

(1) Studies that quantify the outcomes of RA-PA Dual Lumen Cannulation with oxygenation in patients with acute respiratory failure. Clinical and economic outcomes to quantify and compare the efficacy and safety of ProtekDuo vs conventional veno-veno cannulation. Clinical outcomes including early ambulation, RV function, mechanical ventilation dependency, ability to connect or disconnect the oxygenator without interruption of support, ICU length of stay, total length of stay, recovery time, hospital costs, staff dependency, complications, and mortality are of interest. Economic analyses may include cost effectiveness analyses, cost consequence analyses, and budget impact models.
             
(2) Studies that compare VA-ECMO using LifeSPARC to other temporary percutaneous heart pumps in patients with acute cardiac insufficiency. Clinical and economic outcomes to quantify and compare the efficacy, safety, and healthcare utilization for patients treated with LifeSPARC compared to other heart pumps. Clinical outcomes including time to ambulation, blood product use, central venous pressure, recovery time, ICU length of stay, total length of stay, hemodynamic parameters, complications, and mortality are of interest. Economic analyses may include cost effectiveness analyses, cost consequence analyses, and budget impact models.

(3) Usability studies that evaluate the implementation of an ECMO program utilizing LifeSPARC. Usability and clinical outcomes to quantify and compare the ease of use of the ECMO program using LifeSPARC. Outcomes including set up time, rapid initiation, number of FTE required to implement the program, staff dependence (total cost of support staff). Key interests include the correlation of rapid initiation and with clinical and economic outcomes, number of staff to manage the device and patient post insertion, cost savings compared to conventional programs.
 
To be eligible to receive support for IIR, the following conditions must be met: 

1) The research for which support is being sought must be within the therapeutic areas that are served by LivaNova. Proposals that are aligned with the areas of interest set out above will receive the highest priority for review and funding.

2) Applications must be submitted by or on behalf of a legal entity/organization - funds/products can only be provided to organizations, and not individuals acting on their own.

3) All required information and supporting documentation must be provided. LivaNova may reach out to the applicant with follow up questions in relation to the provided material. Incomplete requests may be rejected or delayed. 

In order to request IIR support for research that involves the use of LivaNova devices,

Download the request form here

For requests for educational grants and equipment, sponsorship, and charitable donations/indigent care, please visit our Donations and Grants page and complete the corresponding application.  
 
Important Dates and Deadlines
Requests for IIR support are reviewed periodically throughout the year. Please see below for application deadline and review cycles.  
 

Applications accepted until: IIR Review Board Meeting Notification of decision by:
March 26, 2021 May 6, 2021 June 11, 2021
June 11, 2021 July 22, 2021 August 27, 2021
September 10, 2021 October 19, 2021 November 26, 2021
 

 

Submissions will be reviewed by the Research Committee based on scientific merit, strategic fit, study feasibility, investigator’s qualification, and clinical relevance. All budgets must be in alignment with Fair Market Value (FMV). For additional information, please contact livanova.iir.nm@livanova.com
for requests related to the LivaNova Neuromodulation portfolio, livanova.iir.acs@livanova.com
for requests related to the Advanced Circulatory Support portfolio, or livanova.iir.cs@livanova.com
for requests related to the LivaNova Cardiovascular portfolio.