Supraventricular Arrhythmias
Conditions
Brief summary
To collect supraventricular tachycardia (SVT) data for developing and testing sensing and detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).
Detailed description
The purpose of the SVT Collect study is to collect supraventricular tachycardia episode data for developing and testing new sensing and detection algorithms for a future subcutaneous ICD.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the trial is being conducted * Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant or ICD/CRT-D change-out, OR subjects indicated for an ICD/CRT-D that are undergoing ablation or electrophysiology (EP) study (including Non-invasive EP Study \[NIPS\]) * Subjects are willing to provide Informed Consent
Exclusion criteria
* Subjects who are ventricular pacing dependent * Subjects with a preexisting dual/triple chamber pacemaker or ICD who have a history of atrioventricular (AV) block with atrial pacing \< 120 beats per minute (BPM) while awake. * Subjects who are unable to tolerate elevated ventricular rates (≥170BPM) * Any condition which precludes the subject's ability to comply with the study requirements * Enrollment in a concurrent study (without prior study management approval) that may confound the results of this study * Subjects who are legally incompetent * Subjects meet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Electrocardiograms (ECGs) Collected | After recorded ECGs had been received, which were collected until the end of the indicated procedure | Collected were the number of ECGs received from the enrolled subjects, the number of ECGs with SVT (supraventricular tachycardia) episodes, and the number of ECGs with SVT episodes qualified for algorithm development and validation of the potential new ICD. The ECG data were collected continuously during the indicated procedure (ICD/CRT-D implant, ICD/CRT-D change-out, electrophysiology (EP) study (including non invasive EP study) |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICD Indicated Subjects Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-Invasive ElectroPhysiology Study \[NIPS\]). | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | no procedure according to CIP done | 3 |
| Overall Study | no qualified dataset | 24 |
Baseline characteristics
| Characteristic | ICD Indicated Subjects |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 14 |
| Atrial arrhythmias | 15 participants |
| Congestive Heart Failure | 31 participants |
| Coronary Artery Disease | 24 participants |
| Hypertension | 25 participants |
| Indication for cardiac resynchronization therapy defibrillator (CRT-D) | 6 participants |
| Indication for implantable cardioverter defibrillator (ICD) | 47 participants |
| Previous myocardial infarction | 17 participants |
| Region of Enrollment China | 2 participants |
| Region of Enrollment Hong Kong | 11 participants |
| Region of Enrollment Hungary | 6 participants |
| Region of Enrollment Slovakia | 13 participants |
| Region of Enrollment Taiwan | 21 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 37 Participants |
| Sinus arrhythmias | 13 participants |
| Sinus atrioventricular (AV) junctional arrhythmias and blocks | 23 participants |
| Ventricular arrhythmias | 42 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
Number of Electrocardiograms (ECGs) Collected
Collected were the number of ECGs received from the enrolled subjects, the number of ECGs with SVT (supraventricular tachycardia) episodes, and the number of ECGs with SVT episodes qualified for algorithm development and validation of the potential new ICD. The ECG data were collected continuously during the indicated procedure (ICD/CRT-D implant, ICD/CRT-D change-out, electrophysiology (EP) study (including non invasive EP study)
Time frame: After recorded ECGs had been received, which were collected until the end of the indicated procedure
Population: Total number of ECGs received from the 80 enrolled subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ICD Indicated Subjects | Number of Electrocardiograms (ECGs) Collected | Number of ECGs received | 77 ECG |
| ICD Indicated Subjects | Number of Electrocardiograms (ECGs) Collected | Number of ECGs with SVT episodes | 67 ECG |
| ICD Indicated Subjects | Number of Electrocardiograms (ECGs) Collected | Number of ECGs with qualified SVT episodes | 53 ECG |