Trial Outcomes & Findings for S-ICD® System IDE Clinical Study (NCT NCT01064076)

NCT ID: NCT01064076

Last Updated: 2017-03-27

Results Overview

Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 330 participants
• Primary outcome timeframe: 180 days
• Results posted on: 2017-03-27

Participant Flow

A total of 33 investigational sites participated in the study, twenty-eight (28) of which were in the United States, 2 in New Zealand, 2 in The Netherlands and 1 in the United Kingdom. A total of 330 patients were enrolled between January 27, 2010 and May 20, 2011.

Of the 330 enrollments, 321 underwent an implant procedure (implant attempt) and 9 were withdrawn prior to the commencement of the implant procedure.

Participant milestones

Measure	S-ICD System This is a single arm study
Overall Study STARTED	321
Overall Study COMPLETED	303
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

S-ICD® System IDE Clinical Study

Baseline characteristics by cohort

Measure	S-ICD System n=321 Participants This is a single arm study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	253 Participants n=5 Participants
Age, Categorical >=65 years	68 Participants n=5 Participants
Age, Continuous	51.9 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	238 Participants n=5 Participants
Region of Enrollment United States	275 participants n=5 Participants
Region of Enrollment Netherlands	16 participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants
Region of Enrollment New Zealand	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: The analysis cohort includes all subjects undergoing an implant attempt.

Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.

Outcome measures

Measure	Single Arm n=321 Participants Cohort includes all subjects undergoing an implant attempt
Percentage of Participants Free of Type I Complications at 180 Days.	99.0 percentage of participants Interval 97.9 to This was a one-sided CI

PRIMARY outcome

Timeframe: Implant/Pre-Discharge

Population: 304 subjects had a complete VF conversion test recorded

Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.

Outcome measures

Measure	Single Arm n=304 Participants Cohort includes all subjects undergoing an implant attempt
Percentage of Participants Who Pass Induced VF Conversion Test	96.5 percentage of participants Interval 93.8 to 98.2

Adverse Events

S-ICD System

Serious events: 52 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Measure	S-ICD System n=321 participants at risk This is a single arm study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cyst	0.31% 1/321 • Number of events 1
Blood and lymphatic system disorders Acute Appendicitis	0.31% 1/321 • Number of events 1
Respiratory, thoracic and mediastinal disorders Acute Hypoxic Respiratory Failure	0.31% 1/321 • Number of events 1
Surgical and medical procedures Adverse Reaction to Medication	1.2% 4/321 • Number of events 4
Cardiac disorders Angina	0.31% 1/321 • Number of events 1
Surgical and medical procedures Bleeding	0.31% 1/321 • Number of events 1
Skin and subcutaneous tissue disorders Erosioin	0.93% 3/321 • Number of events 3
Gastrointestinal disorders GI Disorder	0.93% 3/321 • Number of events 3
Cardiac disorders Heart Failure/Worsening of Heart Failure	3.1% 10/321 • Number of events 15
General disorders Hyponatremia	0.31% 1/321 • Number of events 1
General disorders Inability to Communicate with the Device	0.31% 1/321 • Number of events 1
General disorders Inappropriate Shock: Oversensing	0.93% 3/321 • Number of events 3
General disorders Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)	0.62% 2/321 • Number of events 2
General disorders Incomplete Electrode Connection to the Device	0.31% 1/321 • Number of events 1
Cardiac disorders Myocardial Infarction	1.6% 5/321 • Number of events 5
General disorders Near Syncope/Dizziness/Shortness of Breath/Confusion	0.62% 2/321 • Number of events 2
General disorders Pancreatitis	0.31% 1/321 • Number of events 1
General disorders Pneumonia	0.31% 1/321 • Number of events 1
General disorders Pneumothorax	0.31% 1/321 • Number of events 1
Vascular disorders Stroke	0.31% 1/321 • Number of events 1
General disorders Sub-optimal Electrode Position	0.31% 1/321 • Number of events 1
General disorders Suspected Device Malfunction	0.31% 1/321 • Number of events 1
General disorders Syncope	0.62% 2/321 • Number of events 2
General disorders Device System Infection - Explant	1.2% 4/321 • Number of events 4
General disorders VT Below Conditional Zone	0.31% 1/321 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Worsening of Benign Prostatic Hyperplasia	0.31% 1/321 • Number of events 1
Cardiac disorders Worsening of VT/VF	0.62% 2/321 • Number of events 2

Other adverse events

Measure	S-ICD System n=321 participants at risk This is a single arm study
Surgical and medical procedures Adverse Reaction to Medication	1.2% 4/321 • Number of events 4
Cardiac disorders Atrial Fibrillation/Flutter	5.3% 17/321 • Number of events 17
General disorders Discomfort	7.2% 23/321 • Number of events 27
Surgical and medical procedures Hematoma	1.6% 5/321 • Number of events 6
Surgical and medical procedures Inadequate/Prolonged Healing of Incision Site	1.6% 5/321 • Number of events 5
General disorders Inappropriate Shock	14.0% 45/321 • Number of events 64
Infections and infestations Incision/Superficial Infection	4.7% 15/321 • Number of events 15
General disorders Phantom Shock	1.2% 4/321 • Number of events 6
Surgical and medical procedures Suboptimal Pulse Generator and/or Electrode Position	1.2% 4/321 • Number of events 4
General disorders Syncope	1.2% 4/321 • Number of events 4

Additional Information

Michael Husby, Clinical Studies Manager

Cameron Health, Inc. a subsidiary of Boston Scientific

Phone: 312-402-1877

Email: michael.husby@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place