A Study To Collect Electrical Signals From The Heart Using A Special Lead
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-004828
NCT ID: NCT02772380
Sponsor Protocol Number: ASD2
About this study
The purpose of this study is to collect electrogram data from an investigational lead placed in an extravascular space, for the development of a future Implantable Cardioverter Defibrillator (ICD) system.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Must be undergoing surgical procedure for approved indications for
- Cardiothoracic surgery where a midline sternotomy is planned
- Cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned
- VT ablation procedure with epicardial access
- Implant of a subcutaneous ICD (S-ICD®)
- Implant of a transvenous ICD (single or dual chamber)
- Must be willing to provide informed consent
- Must be ≥ 18 years old
Exclusion Criteria
- Has known hiatus hernia, or moderate or worse pectus excavatum
- Had previous pericarditis or prior sternotomy
- Has known significant Right Ventricle/ Right Ventricular dilation
- Has hypertrophic cardiomyopathy
- Is pacemaker dependent
- Has known skin irritations due to the Covidien Multi-function defibrillation electrode
- Is considered to be at high risk for infection
- Has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months)
- Has New York Heart Association Class IV
- Has myocardial infarction within the last 6 weeks
- Currently has unstable angina
- Has severe aortic stenosis
- Is at high risk of stroke
- Has chronic obstructive pulmonary disease and is oxygen dependent
- Has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure
- Has an implanted active cardiac or non-cardiac device during the ASD2 acute testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- Is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- Has any medical condition that would limit study participation
- Is pregnant, or of childbearing potential and not on a reliable form of birth control
- Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 acute testing procedure
- Meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
- Is legally incompetent
- If at high risk for infection, decision will be based on the local investigator judgment decision
- If at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
- Screening will be based on the local investigator judgment decision
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yongmei Cha, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available