ClinicalTrials.gov
ClinicalTrials.gov Menu

Model 20105 Lead Study

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: NCT02301429
Recruitment Status : Terminated (Low implant success rate(46%). For the successfull implants, 3month FU and available electrical data showed an increase in threshold values for the left atrium)
First Posted : November 25, 2014
Results First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sick Sinus Node Syndrome
Intervention Device: Model 20105
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Model 20105
Hide Arm/Group Description

Receiving the model 20105 Lead

Model 20105: implant and follow-up of study device

Period Title: Overall Study
Started 16
Completed 13
Not Completed 3
Reason Not Completed
not acceptable vascular anatomy             3
Arm/Group Title Model 20105
Hide Arm/Group Description

Receiving the model 20105 Lead

Model 20105: implant and follow-up of study device

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
73.2  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
QRS duration  
Mean (Standard Deviation)
Unit of measure:  Msec
Number Analyzed 16 participants
108.7  (17.6)
1.Primary Outcome
Title All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
Hide Description All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis
Arm/Group Title Model 20105
Hide Arm/Group Description:

Receiving the model 20105 Lead

Model 20105: implant and follow-up of study device

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Adverse Events
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Model 20105
Hide Arm/Group Description

Receiving the model 20105 Lead

Model 20105: implant and follow-up of study device

All-Cause Mortality
Model 20105
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Model 20105
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Injury, poisoning and procedural complications   
Coronary Sinus Dissection  1/13 (7.69%)  1
Iatrogenic pneumothorax  1/13 (7.69%)  1
Surgical and medical procedures   
Coronary Artery Stent Insertion  1/13 (7.69%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Model 20105
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Cardiac disorders   
Atrioventricular nodal reentrant tachycardia  1/13 (7.69%)  1
Angina Pectoris  1/13 (7.69%)  1
Injury, poisoning and procedural complications   
Coronary Sinus Dissection  1/13 (7.69%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Clinical Study manager
Organization: Medtronic Regional Clinical Center
Phone: 0039(0)22 241371
Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT02301429     History of Changes
Other Study ID Numbers: LV DDD
First Submitted: October 20, 2014
First Posted: November 25, 2014
Results First Submitted: September 2, 2016
Results First Posted: October 26, 2016
Last Update Posted: October 26, 2016