NCT04351269

Retrospective Experience Of CIED Implantation

Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 597 (actual)
• Sponsor: Elutia Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.

Detailed description

A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.

Conditions

• Cardiac Disease
• Heart Failure
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CanGaroo Envelope	CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
DEVICE	TYRX Envelope	TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation

Timeline

• Start date: 2020-04-22
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-04-17
• Last updated: 2023-07-21
• Results posted: 2022-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study