Supraventricular Tachycardia Collection Study

NCT02158728 | Completed Results

• 1 other identifier: SVT Collect Study
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Supraventricular Arrhythmias

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Implantable cardioverter defibrillator (ICD) indicated

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Semmelweis University

Budapest, Hungary

Location

Results Point of Contact

• Title: Clinical Research Specialist L. Vainer
• Organization: Medtronic

lidwien.vainer@medtronic.com

+31 43 3566752

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 9, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 13, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)