Supraventricular Tachycardia Collection Study

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02158728
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 16
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University	Budapest		Hungary

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT02158728
• Other Study ID Numbers: SVT Collect Study
• First Posted: Jun 9, 2014
• Last Update Posted: Mar 13, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

Participant Flow

Arm/Group Title	ICD Indicated Subjects
Arm/Group Description	Subjects indicated for ICD/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 EP study [NIPS]) ICD: implantable cardioverter defibrillator CRT-D: cardiac resynchronization therapy defibrillator
Period Title: Overall Study
STARTED	80
COMPLETED	53
NOT COMPLETED	27

Baseline Characteristics

Arm/Group Title	ICD Indicated Subjects
Arm/Group Description	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]).
Overall Participants	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (14)
Sex: Female, Male (Count of Participants)
Female	16 30.2%
Male	37 69.8%
Region of Enrollment (participants) [Number]
Hungary	6 11.3%
Taiwan	21 39.6%
Hong Kong	11 20.8%
Slovakia	13 24.5%
China	2 3.8%
Indication for implantable cardioverter defibrillator (ICD) (participants) [Number]
Number [participants]	47 88.7%
Indication for cardiac resynchronization therapy defibrillator (CRT-D) (participants) [Number]
Number [participants]	6 11.3%
Hypertension (participants) [Number]
Number [participants]	25 47.2%
Congestive Heart Failure (participants) [Number]
Number [participants]	31 58.5%
Coronary Artery Disease (participants) [Number]
Number [participants]	24 45.3%
Previous myocardial infarction (participants) [Number]
Number [participants]	17 32.1%
Sinus atrioventricular (AV) junctional arrhythmias and blocks (participants) [Number]
Number [participants]	23 43.4%
Sinus arrhythmias (participants) [Number]
Number [participants]	13 24.5%
Atrial arrhythmias (participants) [Number]
Number [participants]	15 28.3%
Ventricular arrhythmias (participants) [Number]
Number [participants]	42 79.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Total number of ECGs received from the 80 enrolled subjects.

Arm/Group Title	ICD Indicated Subjects
Arm/Group Description	From the initially 80 enrolled subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or EP study (including Non-invasive EP Study [NIPS]), 53 subjects provided SVT episode data which qualified for developing and testing new sensing and detection algorithms for a new MedtronicICD. SVT episodes with a ventricular response rate of ≥170 BPM are required in the development of the algorithms.
Measure Participants	80
Number of ECGs received	77
Number of ECGs with SVT episodes	67
Number of ECGs with qualified SVT episodes	53

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
Arm/Group Title	ICD Indicated Subjects
Arm/Group Description	Only ICD-indicated subjects undergoing standard ICD/CRT-D implant, ICD/CRT-D change-out, ablation, electrophysiology (EP) study or Non Invasive Programmed Stimulation (NIPS), and who provided a dataset which qualified for developing and testing the sensing and detection algorithms of the new ICD, are included in the analyses.
All Cause Mortality
	ICD Indicated Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ICD Indicated Subjects
	Affected / at Risk (%)	# Events
Total	0/80 (0%)
Other (Not Including Serious) Adverse Events
	ICD Indicated Subjects
	Affected / at Risk (%)	# Events
Total	0/80 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.