Supraventricular ArrhythmiasNCT02158728

Supraventricular Tachycardia Collection Study

An observational study of Supraventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Supraventricular Arrhythmias
How many people: 80 participants
Where: 1 siteHungary
Study dates: Jun 2014to Oct 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Implantable cardioverter defibrillator (ICD) indicated

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Hungary1 site

Semmelweis University
Budapest

Other trials in Hungary

About this study

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

Read the 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.

Conditions: Supraventricular Arrhythmias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02158728
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: After recorded ECGs had been received, which were collected until the end of the indicated procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Oct 2015

First posted9 Jun 2014 (estimated)
Study startJun 2014
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Supraventricular ArrhythmiasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02158728
Sponsor's protocol ID: SVT Collect Study
Status last verified: Jan 2017
First submitted: 5 Jun 2014
Last updated: 13 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Supraventricular Arrhythmias trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supraventricular Tachycardia Collection Study
ClinicalTrials.gov ID: NCT02158728
Acronym / sponsor ID: SVT Collect Study
Conditions: Supraventricular Arrhythmias
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 9 Jun 2014 (estimated)
Results: Posted 13 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Implantable cardioverter defibrillator (ICD) indicated

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

Results and safety

Results posted to the registry on 13 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICD Indicated Subjects	80	53

Primary outcome: Number of Electrocardiograms (ECGs) Collected

Time frame: After recorded ECGs had been received, which were collected until the end of the indicated procedure. Number. Unit: ECG

Measure	ICD Indicated Subjects n = 80
Number of ECGs received	77
Number of ECGs with SVT episodes	67
Number of ECGs with qualified SVT episodes	53

Population analysed: Total number of ECGs received from the 80 enrolled subjects.

Adverse events

Time frame: From the first enrolled patient until the last exited patient. Which is from June 11, 2014 up to October 27, 2015. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICD Indicated Subjects	0 of 80 (0%)	0 of 80 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Supraventricular Arrhythmias

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RecruitingObservational study
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Supraventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Electrocardiograms (ECGs) Collected (time frame: After recorded ECGs had been received, which were collected until the end of the indicated procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017; AzTrials last refreshed its copy on 27 Oct 2026.