Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01442181
First received: October 5, 2010
Last updated: July 17, 2015
Last verified: July 2015
Results First Received: February 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Stroke
Interventions: Procedure: Minimally Invasive Surgery
Other: Medical therapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Minimally Invasive Surgery Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
Medical Therapy Patients are treated with rhythm and rate control medications.

Participant Flow:   Overall Study
    Minimally Invasive Surgery     Medical Therapy  
STARTED     14     11  
COMPLETED     10     8  
NOT COMPLETED     4     3  
patient refused surgery                 1                 0  
no insurance for surgery                 1                 0  
low ejection factor                 0                 1  
Lost to Follow-up                 1                 1  
patient in an additional study                 1                 0  
atrial fibrillation not noted                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Minimally Invasive Surgery Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
Medical Therapy Patients are treated with rhythm and rate control medications.
Total Total of all reporting groups

Baseline Measures
    Minimally Invasive Surgery     Medical Therapy     Total  
Number of Participants  
[units: participants]
  14     11     25  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     3     8  
>=65 years     9     8     17  
Gender  
[units: participants]
     
Female     7     2     9  
Male     7     9     16  
Region of Enrollment  
[units: participants]
     
United States     14     11     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Quality of Life RAND 36-Item Health Survey   [ Time Frame: Change in baseline, 3 month, and 6 month ]

2.  Other Pre-specified:   STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)   [ Time Frame: Change in baseline, 3 month, and 6 month ]

3.  Other Pre-specified:   STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)   [ Time Frame: Change in baseline, 3 month, and 6 month ]

4.  Other Pre-specified:   Montreal Cognitive Assessment (Moca)   [ Time Frame: Change in baseline, 3 month, and 6 month ]

5.  Other Pre-specified:   Directed Fluency; Cowa (Controlled Oral Word Association Test)   [ Time Frame: Change in baseline, 3 month, and 6 month ]

6.  Other Pre-specified:   Hopkins Verbal Learning Test Version A   [ Time Frame: Change in baseline, 3 month, and 6 month ]

7.  Other Pre-specified:   Stroop Color Test   [ Time Frame: Change in baseline, 3 month, and 6 month ]

8.  Other Pre-specified:   Wtar (Wechsler Test of Adult Reading) Word List   [ Time Frame: Baseline ]

9.  Other Pre-specified:   Stroop Word Test   [ Time Frame: Change in Baseline, 3 month, and 6 month ]

10.  Other Pre-specified:   Directed Fluency, Animals   [ Time Frame: Change in Baseline, 3 month, and 6 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide 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: Dr. Thomas Beaver
Organization: UF Healthcare
phone: 352-273-5503
e-mail: thomas.beaver@surgery.ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01442181     History of Changes
Obsolete Identifiers: NCT01413971
Other Study ID Numbers: 433-2009
Study First Received: October 5, 2010
Results First Received: February 24, 2015
Last Updated: July 17, 2015
Health Authority: United States: Institutional Review Board