Supraventricular Tachycardia Collection Study

Completed

• Conditions: Supraventricular Arrhythmias

• Registration Number: NCT02158728
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-10-31
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-23
• Last Update Submitted: 2017-01-23
• Results First Posted: 2017-03-13
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Electrocardiograms (ECGs) Collected	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)

Trial Locations

Locations (1)

Semmelweis University; 🇭🇺 Budapest, Hungary