Retrospective Experience Of CIED Implantation

Aziyo Biologics

Status: Completed

Conditions: Coronary Artery Disease; Cardiac Disease; Heart Failure

Treatments: Device: CanGaroo Envelope; Device: TYRX Envelope

Study type: Observational

Funder types: Industry

Identifiers

NCT04351269

CPR-2212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 597 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017

Exclusion criteria

• Any patient that had a CIED implanted with any other type of envelope
• Any patient that had a CIED implanted prior to March 27, 2017

Trial design

597 participants in 3 patient groups

CanGaroo Envelope

Description:

Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.

Treatment:

Device: CanGaroo Envelope

TYRX Envelope

Description:

Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.

Treatment:

Device: TYRX Envelope

No Envelope

Description:

Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.