Cardiac DiseaseNCT04351269

Retrospective Experience Of CIED Implantation

An observational study of Cardiac Disease and Heart Failure, run by Elutia Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Cardiac Disease, Heart Failure, Coronary Artery Disease
What is being tested?: CanGaroo Envelope and TYRX Envelope
Type of treatment: Medical device
How many people: 597 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2020to 30 Jun 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Male or female patients who underwent a CIED implantation utilizing a CanGaroo Envelope hydrated in saline, a CanGaroo Envelope hydrated in an antibiotic solution, a TYRX Envelope, or no envelope.

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Piedmont Athens Electrophysiology
Athens, Georgia, 30606

Other trials in United States

About this study

Official title: Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology

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.

Read the 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
Being tested: CanGaroo Envelope, TYRX Envelope
Medical subject headings: Heart Diseases, Heart Failure, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CanGaroo EnvelopeDevice
CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
TYRX EnvelopeDevice
TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation

Study groups in NCT04351269
Study group	Role	What they receive
CanGaroo Envelope		Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. Receives: Device: CanGaroo Envelope
TYRX Envelope		Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. Receives: Device: TYRX Envelope
No Envelope		Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Major Infection Post Procedure
Major CIED infections are defined as a CIED infection resulting in one or more of the following:
- CIED system removal
- Any invasive procedure (e.g., pocket opened) without system removal
- Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage
- Death
Measured: 12 months post procedure

Secondary outcomes (1)

Number of Participants With Pocket Related Issues Prompting an Office Visit
Any pocket related issues that prompted an office visit
Measured: 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202030 Jun 2021

First posted17 Apr 2020
Study start22 Apr 2020
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 597 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04351269
Sponsor's protocol ID: CPR-2212
Status last verified: Jul 2023
First submitted: 15 Apr 2020
Last updated: 21 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology
ClinicalTrials.gov ID: NCT04351269
Acronym / sponsor ID: CPR-2212
Conditions: Cardiac Disease, Heart Failure, Coronary Artery Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 597 participants (actual)
Lead sponsor: Elutia Inc.Industry (pharma, biotech, devices)
Study start: 22 Apr 2020 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 17 Apr 2020 (actual)
Results: Posted 18 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
CanGaroo Envelope	–	Device: CanGaroo EnvelopePatients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
TYRX Envelope	–	Device: TYRX EnvelopePatients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
No Envelope	–	–Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Male or female patients who underwent a CIED implantation utilizing a CanGaroo Envelope hydrated in saline, a CanGaroo Envelope hydrated in an antibiotic solution, a TYRX Envelope, or no envelope.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CanGaroo EnvelopeCanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation	Device	CanGaroo Envelope
TYRX EnvelopeTYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation	Device	TYRX Envelope

Primary outcome

Number of Participants With Major Infection Post Procedure
Time frame: 12 months post procedure
Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g., pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death

1 secondary outcome

Number of Participants With Pocket Related Issues Prompting an Office Visit
Time frame: 12 months post procedure

Results and safety

Results posted to the registry on 18 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CanGaroo Envelope	237	165
TYRX Envelope	260	219
No Envelope	100	71

Primary outcome: Number of Participants With Major Infection Post Procedure

Time frame: 12 months post procedure. Count of participants. Unit: Participants

Measure	CanGaroo Envelope n = 165	TYRX Envelope n = 219	No Envelope n = 71
Value	2	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months post-procedure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CanGaroo Envelope	9 of 165 (5.5%)	0 of 165 (0%)	0 of 165
TYRX Envelope	7 of 219 (3.2%)	0 of 219 (0%)	10 of 219
No Envelope	1 of 71 (1.4%)	0 of 71 (0%)	0 of 71

Limitations and caveats (from the sponsor): The limitations of this study are its retrospective, observational nature, non-randomized design, limited duration of follow up, and single-physician design. The lack of randomization may introduce bias in the selection of patients for implantation with CIED envelopes and in the choice between CanGaroo and TYRX Envelopes. Finally, the duration of follow up may not have captured late adverse events, limiting data on longer-term outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
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Not yet recruitingObservational study
NHLBI-Emory Advanced Cardiac CT Reconstruction
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Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerome Riebman, MD study director

Aziyo Biologicgs, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Disease and Heart Failure, run by Elutia Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Major Infection Post Procedure (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04351269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.