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Clinical Trials/CTRI/2019/04/018796
CTRI/2019/04/018796
Recruiting
未知

His Bundle Pacing Registry - HBP Registry

St Jude Medical India Pvt Ltd Abbott0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: I440- Atrioventricular block, first degreeHealth Condition 2: I501- Left ventricular failure, unspecified

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: I440- Atrioventricular block, first degreeHealth Condition 2: I501- Left ventricular failure, unspecified
Sponsor
St Jude Medical India Pvt Ltd Abbott
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
St Jude Medical India Pvt Ltd Abbott

Eligibility Criteria

Inclusion Criteria

  • •Subjects must meet the following inclusion criteria for enrollment in the registry.
  • •1\. Scheduled for implantation of a de novo Abbott pacemaker, defibrillator, or CRT\-P/D device with a pacing lead located at the His bundle according to the clinical siteâ??s routine care
  • •2\. At least 18 years of age
  • •3\. Willing and able to comply with the prescribed follow\-up tests and schedule of evaluations
  • •4\. Provided written informed consent prior to any registry\-related procedures

Exclusion Criteria

  • •Subjects will be excluded from enrollment if any of the exclusion criteria is met below.
  • •1\. History of tricuspid valve repair or replacement
  • •2\. Currently participating in another clinical study with an active treatment arm and belong to the active arm
  • •3\. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigatorâ??s opinion, could limit the subjectâ??s ability to participate in the registry or to comply with follow\-up requirements, or impact the scientific soundness of the registry results
  • •4\. Previous failed HBP implant
  • •5\. Life expectancy of less than 6 months
  • •6\. Known contraindication for an HBP implant (i.e. ongoing infection, known inclusion of the subclavian vein, etc.)

Outcomes

Primary Outcomes

Not specified

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