Ventricular Arrhythmias
Conditions
Brief summary
The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.
Detailed description
The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure. The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care. Subjects were followed through their routine post-surgery follow-up visit. At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.
Interventions
Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be undergoing surgical procedure for approved indications for * cardiothoracic surgery where a midline sternotomy is planned, or * implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or * VT ablation procedure, or * VT inducibility testing during Electrophysiology (EP) study * Subject must be willing to provide Informed Consent * Subject must be ≥ 18 years old
Exclusion criteria
* Subject is considered to be at high risk for infection * Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20% * Subject at high risk of stroke * Subject with an implanted active cardiac or non-cardiac device during study procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator) * Subject is pacemaker dependent * Subject had previous pericarditis or prior sternotomy * Subject has hiatus hernia or moderate or worse pectus excavatum * Subject has hypertrophic cardiomyopathy * Subject has severe aortic stenosis * Subject has severe proximal three vessel coronary disease (over 70% in each vessel) * Subject has \>50% left main stem (LMS) disease * Subject has known skin irritations to the Physio Control Fast Patch ECG Electrode * Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager * Subject has medical conditions that would limit study participation * Subject is pregnant * Subject meets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defibrillation Outcome | Day of procedure | Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system. |
Countries
Hong Kong, Netherlands, Poland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Subjects All subjects consented for the study. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Enrolled Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 61.6 years |
| Gender Female | 4 Participants |
| Gender Male | 12 Participants |
| Primary Indication for Surgery Aortic Aneurysm | 1 Participants |
| Primary Indication for Surgery Cardiac Surgery: Coronary Artery Bypass Graft | 2 Participants |
| Primary Indication for Surgery Cardiac Surgery: Valve Repair | 2 Participants |
| Primary Indication for Surgery Cardiac Surgery: Valve Replacement | 5 Participants |
| Primary Indication for Surgery Surgery Related to ICD (transvenous) | 1 Participants |
| Primary Indication for Surgery Surgery Related to S-ICD (subcutaneous ICD) | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United Kingdom Hong Kong | 7 Participants |
| Region of Enrollment United Kingdom Netherlands | 1 Participants |
| Region of Enrollment United Kingdom Poland | 3 Participants |
| Region of Enrollment United Kingdom United Kingdom | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 16 |
| serious Total, serious adverse events | 5 / 16 |
Outcome results
Primary
Defibrillation Outcome
Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.
Time frame: Day of procedure
Population: Only subjects with ventricular fibrillation successfully induced were eligible for analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VF Induction and Defibrillation | Defibrillation Outcome | VF Successfully Terminated with 35J shock | 13 Participants |
| VF Induction and Defibrillation | Defibrillation Outcome | VF Not Successfully Terminated with 35J shock | 1 Participants |
Comparison: Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination \> 65%