Prospective, multicenter, randomized controlled, non inferiority clinical trials to evaluate the safety and efficacy of nanomembrane obturator for patent foramen ovale

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2020
INTERVENTION: Trial group:Implantation of nano membrane obturator for patent foramen ovale;Control group:Implantation of cardi‐o‐fix patent foramen ovale occluder; CONDITION: Patent foramen ovale PRIMARY OUTCOME: Successful rate of effective occlusion 12 months after operation; SECONDARY OUTCOME: Success rate of occluder implantation; INCLUSION CRITERIA: 1) The age of the patients was 18‐65 years old; 2) Be able to understand the purpose of the experiment, participate voluntarily and sign the informed consent form; 3) The presence of PFO was confirmed by tee or TTE; 4) Right heart contrast echocardiography (ctte) or transcranial Doppler foaming test (ctcd) confirmed the presence of moderate to large right to left shunt (calm state or after Valsalva maneuver or cough); 5) At least one of the following clinical conditions exists: a) Stroke of unknown origin complicated with PFO; e) Transient ischemic attack of unknown cause complicated with PFO; f) Recurrent migraine with PFO.
Epistemonikos ID: 996364961f79639ca4183f6455f4339c643637be
First added on: Dec 20, 2022