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

Recruiting
18 years - 65 years
All
500 participants needed
1 Location

Brief description of study

This study is a prospective, multi-center will enroll up to 500 participants (in approximately a 2:1 ratio) who are undergoing implantation of a CIED with either a CanGaroo envelope or no envelope. The CanGaroo Envelope is designed to absorb over time, releasing its intrinsic biologic signals which trigger site-specific tissue remodeling when implanted in the body. This can help mitigate device implant site complications by securing an implanted device within the surgical pocket.

Detailed description of study

This study is a prospective, multi-center will enroll up to 500 participants (in approximately a 2:1 ratio) who are undergoing implantation of a CIED with either a CanGaroo envelope or no envelope. The CanGaroo Envelope is designed to absorb over time, releasing its intrinsic biologic signals which trigger site-specific tissue remodeling when implanted in the body. This can help mitigate device implant site complications by securing an implanted device within the surgical pocket.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: CanGaroo, CIED Implantation
  • Age: 18 years - 65 years
  • Gender: All

Ages 18 to 65 Surgery to implant a medical device which helps the heart

Updated on 04 Aug 2024. Study ID: 849103

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