ISSUE3: International Study on Syncope of Uncertain Etiology 3

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00359203
First received: July 31, 2006
Last updated: October 24, 2013
Last verified: October 2013
Results First Received: May 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Syncope
Intervention: Device: Dual chamber pacemeker

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From April 2007 to April 2011, 89 out of 511 patients (pts) implanted with implantable loop recorder (ILR) documented an asystolic syncope of >=3 sec or a non-syncopal asystole of >= 6 sec, inclusion criteria to be implanted with a dual chamber pacemaker (PM) and randomized to PM on or PM off. 77 pts out of 89 eligible pts were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 out of 89 eligible pts refused randomization

Reporting Groups
  Description
Dual Chamber Pacemaker OFF Implant dual chamber pacemaker programmed ODO (switched OFF)
Dual Chamber Pacemeker ON Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON

Participant Flow:   Overall Study
    Dual Chamber Pacemaker OFF     Dual Chamber Pacemeker ON  
STARTED     39     38  
COMPLETED     39     38  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
Dual Chamber Pacemaker OFF Implant dual chamber pacemaker programmed ODO (switched OFF)
Dual Chamber Pacemeker ON Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
Total Total of all reporting groups

Baseline Measures
    Dual Chamber Pacemaker OFF     Dual Chamber Pacemeker ON     Total  
Number of Participants  
[units: participants]
  39     38     77  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     17     39  
>=65 years     17     21     38  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 12     63  ± 14     63  ± 13  
Gender  
[units: participants]
     
Female     23     18     41  
Male     16     20     36  
Region of Enrollment  
[units: participants]
     
Italy     20     16     36  
Spain     8     8     16  
Netherlands     1     0     1  
Austria     1     0     1  
Germany     3     4     7  
Canada     1     2     3  
France     2     3     5  
Switzerland     1     0     1  
United Kingdom     2     5     7  



  Outcome Measures

1.  Primary:   Syncope Recurrence Rate   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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: Silvia Giuli
Organization: Medtronic Italia SpA
phone: 003932814224
e-mail: silvia.giuli@medtronic.com


No publications provided by Medtronic Bakken Research Center

Publications automatically indexed to this study:

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00359203     History of Changes
Other Study ID Numbers: ISS3
Study First Received: July 31, 2006
Results First Received: May 22, 2013
Last Updated: October 24, 2013
Health Authority: Italy: Ministry of Health