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Completed

NCT Number: NCT02158728

Supraventricular Tachycardia Collection Study

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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Key information

Conditions

Supraventricular Arrhythmias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University

Budapest, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Number of Electrocardiograms (ECGs) Collected

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2014
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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