Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System (09k003)

• ClinicalTrials.gov Identifier: NCT00968032
• Recruitment Status: Completed
• First Posted: August 28, 2009
• Results First Posted: March 9, 2011
• Last Update Posted: June 2, 2011
• Sponsor: pfm medical ag
• Collaborator: MDT Medical Device Testing GmbH
• Information provided by: pfm medical ag

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Foramen Ovale, Patent; Heart Catheterization; Heart Septal Defects, Atrial
• Intervention: Device: Nit-Occlud® PFO
• Enrollment: 63

Participant Flow

Recruitment Details	The recruitment period was set between June 2009 and July 2010 at a single medical clinic.
Pre-assignment Details	No enrolled participants were excluded from the trial.

Arm/Group Title	Nit-Occlud® PFO Implantation Group
Arm/Group Description	Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device
Period Title: Overall Study
Started	63
Completed	61 [1]
Not Completed	2
[1] 1 patient not receiving investigational device due to failure in usage 1 patient denied latest FU

Baseline Characteristics

Arm/Group Title		Nit-Occlud® PFO
Arm/Group Description		[Not Specified]
Overall Number of Baseline Participants		63
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	63 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	61 96.8%
	>=65 years	2 3.2%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	63 participants
		45.7 (11.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	63 participants
	Female	26 41.3%
	Male	37 58.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Germany	Number Analyzed	63 participants
		63

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Successful Implantation.
Description	The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.
Time Frame	6 weeks ± 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nit-Occlud® PFO
Arm/Group Description:	[Not Specified]
Overall Number of Participants Analyzed	63
Measure Type: Number; Unit of Measure: participants
	62

Adverse Events

Time Frame	Adverse Events were observed for each patient during a 6 week FU period (6 weeks +- 2 weeks). Adverse events were judged by the relationship to the investigational device
Adverse Event Reporting Description	No AE led to discontinuation of the study. Causal relationship to the device was not ruled out in 19 AEs. Within these, for 15 AEs the relationship was recorded as unknown, 2 AEs were recorded as possibly related, and 2 AEs were recorded as related. All device related AEs were reported as of mild intensity.
Arm/Group Title	Nit-Occlud® PFO
Arm/Group Description	[Not Specified]
All-Cause Mortality
	Nit-Occlud® PFO
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Nit-Occlud® PFO
	Affected / at Risk (%)	# Events
Total	0/63 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Nit-Occlud® PFO
	Affected / at Risk (%)	# Events
Total	19/63 (30.16%)
Cardiac disorders
Cardiac General † 1	5/63 (7.94%)	5
Cardiac Arrhythmia † 1	3/63 (4.76%)	3
Other † 1	2/63 (3.17%)	2
General disorders
Constitutional Symptoms † 1	3/63 (4.76%)	3
Pain † 1	1/63 (1.59%)	1
Nervous system disorders
Neurology † 1	4/63 (6.35%)	4
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper respiratory † 1	1/63 (1.59%)	1
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAE (3.0)

Limitations and 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.

Results Point of Contact

• Name/Title: Christof Schmeer
• Organization: pfm medical ag
• Phone: +49 6873 9011 ext 41
• EMail: christof.schmeer@pfmmedical.com

• Responsible Party: Christof Schmeer head of quality assurance pfm group, pfm medical ag
• ClinicalTrials.gov Identifier: NCT00968032
• Other Study ID Numbers: 09k003
• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Results First Submitted: January 27, 2011
• Results First Posted: March 9, 2011
• Last Update Posted: June 2, 2011