N/A
Completed N=80
Supraventricular Tachycardia Collection Study
Supraventricular Arrhythmias
Source: ClinicalTrials.gov NCT02158728 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Number of Electrocardiograms (ECGs) Collected — 77; 67; 53 ECG
Summary
To collect supraventricular tachycardia (SVT) data for developing and testing sensing and detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Electrocardiograms (ECGs) Collected |
77; 67; 53 | — |
Eligibility Criteria
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 exclusion criteria required by local laws and regulations (e.g. age, breast feeding, etc).
Data sourced from ClinicalTrials.gov (NCT02158728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.