N/A N=80

Supraventricular Tachycardia Collection Study

Supraventricular Arrhythmias

Bottom Line

View on ClinicalTrials.gov: NCT02158728 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Number of Electrocardiograms (ECGs) Collected — 77; 67; 53 ECG

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Electrocardiograms (ECGs) Collected	77; 67; 53	—

Summary

To collect supraventricular tachycardia (SVT) data for developing and testing sensing and detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).

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).

View full record on ClinicalTrials.gov →

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.