Post-Market Registry for Patients with Emphysema Treated with BTVA in India

ptake Medical BV0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

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•1.Patients who have heterogeneous emphysema, as evidenced by high-resolution CT demonstrating a heterogeneity Index greater than 1.2 in at least one segment to be treated; 2.Patients must be greater than or equal to 18 years of age; 3.Patients must have the capacity to provide informed consent and are required to provide informed consent prior to inclusion in this registry.

•1.FEV1 is less than 20% predicted; 2.DLCO is less than 20% predicted; 3.Inability to walk is more than 140 meters in 6 minutes (6MWD) following optimized medical management; 4.Unstable COPD (any of the following): a.more than 3 COPD related hospitalizations requiring antibiotics in past 12 months b.COPD related hospitalization in past 3 months c.daily use of systemic steroids, i.e.more than 5 mg prednisolone; 5.Unable to discontinue anti-coagulants or platelet inhibitors (non-ASA and ASA is more than 100mg daily) pre-procedure and for at least 6 weeks post-procedure; 6.Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor Newly prescribed morphine derivatives within the last 4 weeks 7.Newly prescribed morphine derivatives within the last 4 weeks; 8.Pregnant or breastfeeding; 9.Highly diseased lower lobes (tissue to air ratio is less than 11%); 10.Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count); 11.Presence of single large bulla (defined as more than 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe; 12.Recent respiratory infections or COPD exacerbation in preceding 6 weeks;

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ptake Medical BV