Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry (ASC ICD Reg)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03604133 |
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Recruitment Status :
Recruiting
First Posted : July 27, 2018
Last Update Posted : January 22, 2021
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Sponsor:
QuesGen Systems Inc
Collaborator:
Cardio Surgical Partners
Information provided by (Responsible Party):
QuesGen Systems Inc
| Tracking Information | |||||||||
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| First Submitted Date | July 18, 2018 | ||||||||
| First Posted Date | July 27, 2018 | ||||||||
| Last Update Posted Date | January 22, 2021 | ||||||||
| Actual Study Start Date | August 24, 2017 | ||||||||
| Estimated Primary Completion Date | August 24, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Successful Implantation [ Time Frame: Two-week follow-up assessment ] Patient undergoes surgery for ICD device implantation
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry | ||||||||
| Official Title | Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry | ||||||||
| Brief Summary | The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Weeks | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Individuals who require ICD to maintain optimal health. | ||||||||
| Condition | Arrhythmia | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Patients receiving ICD devices | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 24, 2028 | ||||||||
| Estimated Primary Completion Date | August 24, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03604133 | ||||||||
| Other Study ID Numbers | 2018-310 Cardiac Registry | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | QuesGen Systems Inc | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | QuesGen Systems Inc | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Cardio Surgical Partners | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | QuesGen Systems Inc | ||||||||
| Verification Date | January 2021 | ||||||||