{"protocolSection":{"identificationModule":{"nctId":"NCT03191656","orgStudyIdInfo":{"id":"1701"},"briefTitle":"REDUCE LAP-HF III Corvia Protocol 1701","officialTitle":"A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure"},"descriptionModule":{"briefSummary":"This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a \"real world\" practice setting."},"conditionsModule":{"conditions":["Heart Failure"]},"eligibilityModule":{"eligibilityCriteria":"This is a post market registry so no criteria requirements (only recommendations).","healthyVolunteers":false,"sex":"ALL","minimumAge":"40 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"Patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy (GDMT), in accordance with CE-mark approved labeling.","samplingMethod":"NON_PROBABILITY_SAMPLE"}}}