多極冠状静脈洞リードファミリーACUITY® X4を使用したCRT配信の最大化 - RALLY X4研究

基本情報

NCT ID

NCT02066467

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

863

治験依頼者名

Boston Scientific Corporation

概要

The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting. It is a prospective, non-randomized, observational multicenter study evaluating standard of care. For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant. Study endpoints: Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.

対象疾患

介入

依頼者（Sponsor）

実施施設 (11)