HBP Device EGM Data Collection
His Bundle Pacing Device Electrogram Data Collection
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.
Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.
The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Alabama
-
Huntsville、Alabama、美国、35801
- *Heart Center Research, LLC.
-
-
Pennsylvania
-
Sayre、Pennsylvania、美国、18840
- Donald Guthrie Foundation for Education & Research
-
-
South Carolina
-
Greenville、South Carolina、美国、29605
- Greenville Health System
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Has previously implanted with Abbott device and any pacing lead at HB
- Age ≥ 18 years
- Ability to provide informed consent for study participation
- Willing to comply with study evaluation requirements
Exclusion Criteria:
- Suspected pacing system failure
- Lead impedance out of range
- Ventricular sensing amplitude lower than 0.5 mV
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
HBP device data collection group
Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit.
|
Collection of device electrograms and 12-lead ECG during a device follow-up visit
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Amplitude of device electrogram
大体时间：through study completion, an average of 1 year
|
Mean amplitude of device electrogram during His bundle pacing
|
through study completion, an average of 1 year
|
|
Duration of device electrogram
大体时间：through study completion, an average of 1 year
|
Mean duration of device electrogram during His bundle pacing
|
through study completion, an average of 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Device data collection的临床试验
-
Steno Diabetes Center CopenhagenUniversity of Southern Denmark; Steno Diabetes Center Sjaelland主动，不招人
-
St. Louis UniversityLucerno Dynamics Limited Liability Company (LLC)完全的
-
Taipei Veterans General Hospital, TaiwanLotung Poh-Ai Hospital未知