Trial Outcomes & Findings for Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System (NCT NCT00968032)

Last Updated: 2011-06-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

6 weeks ± 2 weeks

Results posted on

2011-06-02

Participant Flow

The recruitment period was set between June 2009 and July 2010 at a single medical clinic.

No enrolled participants were excluded from the trial.

Participant milestones

Participant milestones
Measure	Nit-Occlud® PFO Implantation Group Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device
Overall Study STARTED	63
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nit-Occlud® PFO n=63 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	45.7 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment Germany	63 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks ± 2 weeks

Outcome measures

Outcome measures
Measure	Nit-Occlud® PFO n=63 Participants
Number of Participants With a Successful Implantation.	62 participants

Adverse Events

Nit-Occlud® PFO

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nit-Occlud® PFO n=63 participants at risk
Cardiac disorders Cardiac General	7.9% 5/63 • Number of events 5 • 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 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.
Nervous system disorders Neurology	6.3% 4/63 • Number of events 4 • 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 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.
Cardiac disorders Cardiac Arrhythmia	4.8% 3/63 • Number of events 3 • 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 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.
General disorders Constitutional Symptoms	4.8% 3/63 • Number of events 3 • 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 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.
General disorders Pain	1.6% 1/63 • Number of events 1 • 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 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.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper respiratory	1.6% 1/63 • Number of events 1 • 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 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.
Cardiac disorders Other	3.2% 2/63 • Number of events 2 • 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 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.

Additional Information

Christof Schmeer

pfm medical ag

Phone: +49 6873 9011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place