Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04299282
Other study ID # CPR-2205
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2021
Est. completion date March 2022

Study information

Verified date July 2023
Source Aziyo Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).


Description:

A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - BMI of less than 23. - Already scheduled for or a clinical decision made to have one of the following qualifying CIED implant procedures using a device cleared by the U.S. FDA: - De novo pacemaker, ICD, or S-ICD; - Upgrade or change out of existing CIED to a pacemaker, ICD, or S-ICD - Clinically stable and able to tolerate procedure. - Be able and willing to return for follow-up care through the 3-month visit. - Must possess the ability to provide informed consent. Exclusion Criteria: - Patients with a known sensitivity to porcine material. - Participation in another clinical study. - Active infection. Clinical diagnosis of an active infection at the time of CIED implant (CIED infection, pneumonia, UTI, endovascular, cellulitis, bacteremia, or other major systemic infection). - Female patient who is pregnant, or planning to become pregnant during the length of the study. - Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis in the past 12 months. - Life expectancy of less than 3 months.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CanGaroo
CIED ECM envelope

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aziyo Biologics, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Healing at incision site Improved incision site healing for the CanGaroo group 3 months post CIED implantation
Secondary QOL Survey Patient assessment via Quality of Life Survey 3 months post CIED implantation
Secondary Vascular Tissue Layer Ultrasound measurement of vascular tissue layer 3 months post CIED implantation
Secondary Skin Fold Test Skin fold test measurement for tissue thickness 3 months post CIED implantation
See also
  Status Clinical Trial Phase
Completed NCT04624412 - Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2 N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT04561908 - Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access N/A
Active, not recruiting NCT06190743 - Perception of Cardiovascular Risk
Completed NCT04562636 - Evaluating a Messaging Campaign in the United States N/A
Completed NCT04580095 - Artificial Intelligence for Improved Echocardiography N/A
Recruiting NCT03277365 - MyGeneRank: A Digital Platform for Next-Generation Genetic Studies N/A
Active, not recruiting NCT05553106 - Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Recruiting NCT04390672 - Multivessel TALENT N/A
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02046902 - Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Completed NCT01944254 - The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients N/A
Completed NCT01909349 - Web-based Aftercare Intervention for Cardiac Patients N/A
Recruiting NCT01457586 - Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery Phase 4
Recruiting NCT01207167 - Mediators of Atherosclerosis in South Asians Living in America
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Terminated NCT00968383 - Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment N/A

External Links