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).

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Implantable cardioverter defibrillator (ICD) indicated

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Electrocardiograms (ECGs) Collected	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)	After recorded ECGs had been received, which were collected until the end of the indicated procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: SVT Collect Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO