Trial Outcomes & Findings for Supraventricular Tachycardia Collection Study (NCT NCT02158728)

Last Updated: 2017-03-13

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

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

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	ICD Indicated Subjects 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
Overall Study STARTED	80
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	ICD Indicated Subjects 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
Overall Study no procedure according to CIP done	3
Overall Study no qualified dataset	24

Baseline Characteristics

Supraventricular Tachycardia Collection Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ICD Indicated Subjects n=53 Participants 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 \[NIPS\]).
Age, Continuous	57 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment Hungary	6 participants n=5 Participants
Region of Enrollment Taiwan	21 participants n=5 Participants
Region of Enrollment Hong Kong	11 participants n=5 Participants
Region of Enrollment Slovakia	13 participants n=5 Participants
Region of Enrollment China	2 participants n=5 Participants
Indication for implantable cardioverter defibrillator (ICD)	47 participants n=5 Participants
Indication for cardiac resynchronization therapy defibrillator (CRT-D)	6 participants n=5 Participants
Hypertension	25 participants n=5 Participants
Congestive Heart Failure	31 participants n=5 Participants
Coronary Artery Disease	24 participants n=5 Participants
Previous myocardial infarction	17 participants n=5 Participants
Sinus atrioventricular (AV) junctional arrhythmias and blocks	23 participants n=5 Participants
Sinus arrhythmias	13 participants n=5 Participants
Atrial arrhythmias	15 participants n=5 Participants
Ventricular arrhythmias	42 participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	ICD Indicated Subjects n=80 Participants 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.
Number of Electrocardiograms (ECGs) Collected Number of ECGs received	77 ECG
Number of Electrocardiograms (ECGs) Collected Number of ECGs with SVT episodes	67 ECG
Number of Electrocardiograms (ECGs) Collected Number of ECGs with qualified SVT episodes	53 ECG

Adverse Events

ICD Indicated Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Specialist L. Vainer

Medtronic

Phone: +31 43 3566752

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place