Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: September 28, 2015
Last verified: September 2015
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
  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
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
  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
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
Overall Participants Analyzed 
[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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: September 28, 2015
Health Authority: Italy: Ministry of Health