Supraventricular Tachycardia Collection Study

Medtronic

Status: Completed

Conditions: Supraventricular Arrhythmias

Study type: Observational

Funder types: Industry

Identifiers

NCT02158728

SVT Collect Study

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

80 participants in 1 patient group

ICD indicated subjects

Description:

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 \[NIPS\]). Enrolled subjects are prepared for the indicated procedure as per investigational center's standard practice. The investigator will determine the best methodology for inducing or simulating SVT within the indicated procedure. Data is recorded by a data acquisition recording system. Recording should begin just before the indicated procedure and continue until completion of the procedure.The recorded data are collected.