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Trial record 1 of 1 for:    22565936 [PUBMED-IDS]
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ISSUE3: International Study on Syncope of Uncertain Etiology 3

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ClinicalTrials.gov Identifier: NCT00359203
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : November 18, 2013
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Syncope
Intervention Device: Dual chamber pacemeker
Enrollment 511
Recruitment Details 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 12 out of 89 eligible pts refused randomization
Arm/Group Title Dual Chamber Pacemaker OFF Dual Chamber Pacemeker ON
Hide Arm/Group Description Implant dual chamber pacemaker programmed ODO (switched OFF) Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
Period Title: Overall Study
Started 39 38
Completed 39 38
Not Completed 0 0
Arm/Group Title Dual Chamber Pacemaker OFF Dual Chamber Pacemeker ON Total
Hide Arm/Group Description Implant dual chamber pacemaker programmed ODO (switched OFF) Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON Total of all reporting groups
Overall Number of Baseline Participants 39 38 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  56.4%
17
  44.7%
39
  50.6%
>=65 years
17
  43.6%
21
  55.3%
38
  49.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 38 participants 77 participants
63  (12) 63  (14) 63  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
Female
23
  59.0%
18
  47.4%
41
  53.2%
Male
16
  41.0%
20
  52.6%
36
  46.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 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
1.Primary Outcome
Title Syncope Recurrence Rate
Hide Description Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
77 patients implanted with dual chamber pacemaker: 39 patients randomized to pacemaker OFF and 38 patients randomized to pacemaker ON
Arm/Group Title Dual Chamber Pacemaker OFF Dual Chamber Pacemeker ON
Hide Arm/Group Description:
Implant dual chamber pacemaker programmed ODO (switched OFF)
Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
Overall Number of Participants Analyzed 39 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57
(40 to 74)
25
(13 to 45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dual Chamber Pacemaker OFF, Dual Chamber Pacemeker ON
Comments The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the Pm ON arm applying a log-rank test with a 2-sided significance level of 0.05. This analysis was planned as a comparison of the cumulative risk of syncope between the 2 groups with the use of a log-rank test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Log Rank
Comments The risk of syncope recurrence was based on HR obtained by means of the univarate Cox model, with the use of the Breslow method for ties.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.19 to 0.96
Estimation Comments numerator=pacemaker ON denominator=pacemaker OFF
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dual Chamber Pacemaker OFF, Dual Chamber Pacemeker ON
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the treatment arm applying a log-rank test with a 2-sided significance level of 0.05.
Statistical Test of Hypothesis P-Value 0.039
Comments For the final analysis the threshold of statistical significance was set at 0.04.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.19 to 0.96
Estimation Comments Numerator=pacemaker ON denominator=pacemaker OFF
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dual Chamber Pacemaker OFF Dual Chamber Pacemeker ON
Hide Arm/Group Description Implant dual chamber pacemaker programmed ODO (switched OFF) Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
All-Cause Mortality
Dual Chamber Pacemaker OFF Dual Chamber Pacemeker ON
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dual Chamber Pacemaker OFF Dual Chamber Pacemeker ON
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/39 (7.69%)      3/38 (7.89%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Dead   0/39 (0.00%)  0 1/38 (2.63%)  1
Surgical and medical procedures     
Right ventricle lead dislodgment   2/39 (5.13%)  2 0/38 (0.00%)  0
Right atrium lead dislodgment   0/39 (0.00%)  0 2/38 (5.26%)  2
Subclavian vein thrombosis   1/39 (2.56%)  1 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Dual Chamber Pacemaker OFF Dual Chamber Pacemeker ON
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      2/38 (5.26%)    
Cardiac disorders     
Atrial arrhythmia   0/39 (0.00%)  0 1/38 (2.63%)  1
Gastrointestinal disorders     
Gastroenteritis   0/39 (0.00%)  0 1/38 (2.63%)  1
Indicates events were collected by systematic assessment
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
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00359203     History of Changes
Other Study ID Numbers: ISS3
First Submitted: July 31, 2006
First Posted: August 1, 2006
Results First Submitted: May 22, 2013
Results First Posted: November 18, 2013
Last Update Posted: September 30, 2015