A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation

Status: Active, not recruiting
Location: See all (23) locations...
Intervention Type: Device
Study Type: Observational [Patient Registry]
SUMMARY

A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Participants for whom this is their first CIED implantation at a particular anatomical site.

• Participants with a history of prior CIED implants at other anatomical sites than the current site can be included, provided that the planned implant location for the current CIED procedure is the first implant procedure at that site.

• Participants aged 18 years or older at time of enrollment.

• Participant is able and agrees to provide written informed consent and use of PHI.

Locations
United States
Arkansas
Arkansas Heart Hospital
Little Rock
Florida
Daytona Heart Group
Daytona Beach
The Arrhythmia Center of South Florida
Delray Beach
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale
VA Medical Center
Gainesville
Cardiovascular Associates/Osceola Regional Medical Center
Kissimmee
Advent Health
Tampa
Indiana
Baptist Health Floyd
New Albany
Kentucky
St. Joseph Hospital
Lexington
Massachusetts
Brigham & Women's Hospital, Cardiovascular Division
Boston
Maine
Eastern Maine Medical Center
Bangor
Michigan
Sparrow Clinical Research Institute
Lansing
Ascension Providence Hospital
Southfield
Metro Health/University of Michigan Health
Wyoming
North Carolina
UNC Health/NC Heart & Vascular Research
Raleigh
New Hanover Regional Medical Center
Wilmington
Ohio
Mercy Health
Toledo
Oklahoma
Oklahoma State University Center for Health Sciences
Tulsa
Pennsylvania
University of Pennsylvania Hospital
Philadelphia
South Carolina
Carolina Heart Specialists
Lancaster
Texas
University of Texas Medical Branch
Galveston
Houston Methodist
Houston
Heart Rhythm Associates
The Woodlands
Time Frame
Start Date: May 25, 2021
Estimated Completion Date: June 30, 2027
Participants
Target number of participants: 500
Treatments
CanGaroo Envelope
Participants who receive a CanGaroo envelope during their CIED implant.
No Envelope
Participants who do not receive an envelope of any kind during their CIED implant.
Authors
Rony Gorges, David Lin, Michael Sumners, William Smith, Dipak Shah, Apoor Patel, Nilesh Mathuria, Ramanan Kumareswaran, Mallory Gustafson, Samy Elayi, Mark Ciminelli, John Ip, Jeffrey Arkles, Ali Sheikh, Matthew Hyman, Mark Freher, Thomas F. Deering, Satya Garimella, James Strickland, Paul Gerczuk, Fermin Garcia, Hanscy Seide, Amish Dave, David Frankel, Spyridon Akrivakis, Christian Machado, Yoel Vivas, Saman Nazarian, Miguel Valderrabano, Ramil Goel, Gustavo Guandalini, Deepak Shah, Matthew Sevensma, David Kenigsberg, Steve Kim, Yousef Darrat, Asif Sewani, David Callans, Joseph Falsone, Meena Rao, Gregory Supple, Oliver Abela, Sunil Kapur, Michael Riley, Robert Schaller, Michael Yarnoz, Matt Wilkett, Mark Catellani, Naushad Shaik, Paul Schurmann Perez, Juan Andres Merchan Hakspiel, Luis Fernando Mora Vieira, Ahmed Osman, Christopher Bradley, Ameer Kabour, Hemindermeet Singh, Pasquale Santangeli, Rajat Deo, Scott Beau
Sponsors
Leads: Aziyo Biologics, Inc.

This content was sourced from clinicaltrials.gov

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