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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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

Arm/Group Title Nit-Occlud® PFO
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 63
Hide 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
1.Primary Outcome
Title Number of Participants With a Successful Implantation.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nit-Occlud® PFO
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
62
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
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Nit-Occlud® PFO
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Nit-Occlud® PFO
Affected / at Risk (%) # Events
Total   0/63 (0.00%)    
Hide 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)
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
Layout table for Results Point of Contact information
Name/Title: Christof Schmeer
Organization: pfm medical ag
Phone: +49 6873 9011 ext 41
EMail: christof.schmeer@pfmmedical.com
Layout table for additonal information
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