Supraventricular Tachycardia Collection Study

Supraventricular Arrhythmias Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02158728
• Other study ID #: SVT Collect Study
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2014
• Last updated: June 6, 2014
• Start date: June 2014
• Est. completion date: July 2016

Study information

• Verified date: June 2014
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: SVT Collect Study Manager
• Phone: 800-328-2518
• Email: medtronicCRMtrials[@]medtronic.com
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics Committee
• Study type: Observational

Clinical Trial Summary

To collect SVT data for developing and testing sensing and detection algorithms for a subcutaneous ICD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ICD/CRT-D implant or ICD/CRT-D change-out, OR subjects indicated for an ICD/CRT-D that are undergoing ablation or 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 AV block with atrial pacing < 120 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Supraventricular Arrhythmias
• Tachycardia, Supraventricular

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ECGs collected during SVT episodes		1 day	No