Chronic II: Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00853645
• Collaborator: (none)
• Enrollment: 6
• Locations: 2
• Arm: 1
• Actual Duration (Months): 2
• Patients Per Site: 3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachyarrhythmias	Device: Subcutaneous Implantable Defibrillator (S-ICD) System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
• Actual Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subcutaneous implantable cardioverter defibrillator (S-ICD) System Single-arm with 6 patients implanted with an S-ICD System	Device: Subcutaneous Implantable Defibrillator (S-ICD) System

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Successful Induced Ventricular Fibrillation Conversion [30 days]

   Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• replacement of an existing transvenous implantable cardioverter defibrillator (ICD) system

• American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation

• Age >= 18 years

• Appropriate pre-operative Electrocardiogram (ECG) as measured with a specially developed template

Exclusion Criteria:

• Subjects unable or unwilling to provide informed consent

• Any condition which precludes the subject's ability to comply with the study requirements

• Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study

• Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.

• Patients with a serious medical condition and life expectancy of less than one year.

• Patients with documented spontaneous and frequently recurring ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing

• Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant

• Patients with chronic renal failure, i.e. with a creatinine level of >2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be <= 3mg/dl

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auckland City Hospital	Auckland		New Zealand	1001
2	Christchurch Hospital	Christchurch		New Zealand	8140

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Stephen O'Connor, PhD, Hon FRACP, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00853645
• Other Study ID Numbers: DN-11398
• First Posted: Mar 2, 2009
• Last Update Posted: Jul 6, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular

Study Results

Participant Flow

Arm/Group Title	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Arm/Group Description	Single-arm with 6 patients implanted with an S-ICD System
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Arm/Group Description	Single-arm with 6 patients implanted with an S-ICD System
Overall Participants	6
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.24 (11.42)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	6 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
New Zealand	6 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
Description	Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Arm/Group Description	Single-arm with 6 patients implanted with an S-ICD System
Measure Participants	6
Count of Participants [Participants]	6 100%

Adverse Events

Time Frame	1 month
Arm/Group Title	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Arm/Group Description	Single-arm with 6 patients implanted with an Subcutaneous implantable cardioverter defibrillator (S-ICD) System
All Cause Mortality
	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Cardiac disorders
Severe acute coronary syndrome.	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
	Affected / at Risk (%)	# Events
Total	4/6 (66.7%)
Product Issues
Pulse generator rotation	3/6 (50%)	3
Inappropriate paced beats post shock	1/6 (16.7%)	1
Surgical and medical procedures
Electrode removed and retunneled at implant	1/6 (16.7%)	1

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.