Research Project
9581254
Summary Myocardial catheter ablation is commonly performed for the treatment of rhythm disorders, using radiofrequency energy, typically guided using X-ray and/or electromagnetic positioning. Available non-surgical technologies do not allow clear depiction of myocardium being ablated. MRI-guided needle catheter chemo-ablation, for example using focal injection of caustic agents such as acetic acid doped with MRI contrast agents, may allow targeted disruption of small segments of myocardium in the treatment of rhythm disorders such as ventricular tachycardia and in the treatment of structural heart disease such as hypertrophic cardiomyopathy. Preclinical feasibility of at least two different MRI injection needle catheter systems has been demonstrated and published for the application of direct endomyocardial cell injection, including by our labs. No commercial options are available. An MRI myocardial needle injection catheter system may enable a new family of non-surgical cardiovascular treatments for rhythm and structural heart disease. Project Goals The goal of the project is to develop an endomyocardial injection needle chemoablation catheter that is safe for operation during MRI, to allow targeted myocardial delivery of caustic agents. First a prototype would be developed and tested in animals, and ultimately a clinical-grade device would undergo regulatory development for clinical testing. NIH offers to perform clinical testing at no charge to the contractor. Offerors are encouraged to include concrete milestones in their proposals, along with detailed research and development plans, risk analysis, and contingency plans, both for Phase I and Phase II. Proposals must include a detailed description of the regulatory strategy, including plans for a pre-submission meeting with the US Food and Drug Administration (FDA) in Phase I. Offerors must include key personnel on the project with appropriate and relevant regulatory experience. Offerors are advised to plan travel to NHLBI in Bethesda, Maryland, and are expected to plan meetings at project initiation, mid-project to determine what iteration is necessary, and at project completion.
