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Supraventricular Tachycardia Collection Study

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ClinicalTrials.gov Identifier: NCT02158728
Recruitment Status : Completed
First Posted : June 9, 2014
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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

Condition or disease
Supraventricular Arrhythmias

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Implantable cardioverter defibrillator (ICD) indicated
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158728


Locations
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Hungary
Semmelweis University
Budapest, Hungary
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02158728    
Other Study ID Numbers: SVT Collect Study
First Posted: June 9, 2014    Key Record Dates
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes