Long-term Safety Study of the GORE® HELEX® Septal Occluder

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

W.L.Gore & Associates

ClinicalTrials.gov Identifier:

NCT00581308

First received: December 20, 2007

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Results First Received: January 4, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Septal Defect, Atrial
Intervention:	Device: GORE® HELEX® Septal Occluder

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Data was combined from the following sources: (1) Continued Access Study of the GORE® HELEX® Septal Occluder (PMA Subjects HLX 03-01 – last 87 non-training subjects) and (2) subjects implanted with the HELEX device enrolled in the Post-Approval Study of the GORE® HELEX® Septal Occluder (n=128). The total number of subjects enrolled is 215.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only subjects with a successful implant of the device were included from each study.

Reporting Groups

	Description
PAS Subjects	Subjects with occluder in place upon leaving cath lab

Participant Flow for 4 periods

Period 1: Pre Discharge

	PAS Subjects
STARTED	215
COMPLETED	212
NOT COMPLETED	3
Lost to Follow-up	2
Device Removed	1

Period 2: Month 1

	PAS Subjects
STARTED	212
COMPLETED	203
NOT COMPLETED	9
Lost to Follow-up	4
Withdrawal by Subject	3
Device Removed	2

Period 3: Month 6

	PAS Subjects
STARTED	203
COMPLETED	198
NOT COMPLETED	5
Lost to Follow-up	1
Withdrawal by Subject	4

Period 4: Month 12

	PAS Subjects
STARTED	198
COMPLETED	177
NOT COMPLETED	21
Death	1
Lost to Follow-up	14
Withdrawal by Subject	2
Device Removed	1
Unknown	3

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
PAS Subjects	Subjects with occluder in place upon leaving cath lab

Baseline Measures

	PAS Subjects
Number of Participants [units: participants]	215
Age [units: participants]
<=18 years	188
Between 18 and 65 years	26
>=65 years	1
Age [units: years] Mean ± Standard Deviation
Mean (Standard Deviation)	11.3 ± 12.9
Age, Customized [units: years] Median ( Full Range )	6.5 ( 0.8 to 88.5 )
Gender [units: participants]
Female	130
Male	85
Race/Ethnicity, Customized [units: participants]
White or Caucasian	141
Black or African American	23
Hispanic or Latino	21
Asian	8
Other	16
Unknown	6
Defect Size by Direct Balloon Sizing [units: Participants]
With Value	209
Missing Value	6
Defect Size by Direct Balloon Sizing [units: (mm)] Mean ± Standard Deviation	12 ± 3
Defect Size by Direct Balloon Sizing [units: (mm)] Median ( Full Range )	13 ( 5 to 20 )
Multiple Fenestrations Noted [units: Participants]
Yes	39
No	176
General Medical History: Previous Cardiac Surgery [units: Participants]
Yes	12
No	203
General Medical History: ECG Abnormalities [units: Participants]
Yes	97
No	118
General Medical History: Cardiac Arrhythmia(s) [units: Participants]
Yes	16
No	199
General Medical History: Other (non-ASD) Cardiac Disease [units: Participants]
Yes	28
No	187

Outcome Measures

Hide All Outcome Measures

1. Primary:

Clinical Success Endpoint [ Time Frame: 12 months ]

Measure Type	Primary
Measure Title	Clinical Success Endpoint
Measure Description	No text entered.
Time Frame	12 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects with Successful Device Delivery

Reporting Groups

	Description
PAS Subjects	Subjects with occluder in place upon leaving cath lab

Measured Values

	PAS Subjects
Number of Participants Analyzed [units: participants]	210
Clinical Success Endpoint [units: Participants]
Subjects Evaluated	179
Clinical Success	170
Clinical Failure	9
Major Device/Procedure Adverse Event	8
Significant Leak on Core Lab Evaluation	1
Subjects Not Evaluated	31

No statistical analysis provided for Clinical Success Endpoint

2. Secondary:

Total Time Under Fluoroscopy [ Time Frame: Procedure ]

Measure Type	Secondary
Measure Title	Total Time Under Fluoroscopy
Measure Description	No text entered.
Time Frame	Procedure
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
PAS Subjects	Subjects with occluder in place upon leaving cath lab

Measured Values

	PAS Subjects
Number of Participants Analyzed [units: participants]	213
Total Time Under Fluoroscopy [units: minutes] Mean ± Standard Deviation	19 ± 11

No statistical analysis provided for Total Time Under Fluoroscopy

3. Secondary:

Secondary Outcome: Total Time Under Fluoroscopy [ Time Frame: Procedure ]

Measure Type	Secondary
Measure Title	Secondary Outcome: Total Time Under Fluoroscopy
Measure Description	No text entered.
Time Frame	Procedure
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
PAS Subjects	Subjects with occluder in place upon leaving cath lab

Measured Values

	PAS Subjects
Number of Participants Analyzed [units: participants]	213
Secondary Outcome: Total Time Under Fluoroscopy [units: minutes] Median ( Full Range )	16 ( 0 to 69 )

No statistical analysis provided for Secondary Outcome: Total Time Under Fluoroscopy

4. Secondary:

Days in Hospital for Procedure [ Time Frame: Post Procedure ]

Measure Type	Secondary
Measure Title	Days in Hospital for Procedure
Measure Description	No text entered.
Time Frame	Post Procedure
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
PAS Subjects	Subjects with occluder in place upon leaving cath lab

Measured Values

	PAS Subjects
Number of Participants Analyzed [units: participants]	215
Days in Hospital for Procedure [units: Days] Mean ± Standard Deviation	1 ± 0

No statistical analysis provided for Days in Hospital for Procedure

5. Secondary:

Secondary Outcome: Days in Hospital for Procedure [ Time Frame: Post Procedure ]

Measure Type	Secondary
Measure Title	Secondary Outcome: Days in Hospital for Procedure
Measure Description	No text entered.
Time Frame	Post Procedure
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
PAS Subjects	Subjects with occluder in place upon leaving cath lab

Measured Values

	PAS Subjects
Number of Participants Analyzed [units: participants]	215
Secondary Outcome: Days in Hospital for Procedure [units: Days] Median ( Full Range )	1 ( 0 to 4 )

No statistical analysis provided for Secondary Outcome: Days in Hospital for Procedure

6. Secondary:

Secondary Analyses Will be Performed on All Patients Enrolled With a Device Implanted, Regardless of Meeting Inclusion / Exclusion Criteria or Anatomic Suitability Criteria, Using Data From All Visit Evaluations. [ Time Frame: 1 year postprocedure ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

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

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Joth Jacobson
Organization: W. L. Gore & Associates
phone: (800) 437-8181
e-mail: jjacobso@wlgore.com

No publications provided

Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00581308 History of Changes
Other Study ID Numbers:	HLX 06-04
Study First Received:	December 20, 2007
Results First Received:	January 4, 2012
Last Updated:	December 18, 2012
Health Authority:	United States: Food and Drug Administration

To Top