Supraventricular Tachycardia Collection Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Supraventricular Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 \[NIPS\]).

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No