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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00266682




Registration number
NCT00266682
Ethics application status
Date submitted
16/12/2005
Date registered
19/12/2005
Date last updated
13/10/2006

Titles & IDs
Public title
Clinical Investigation of the SelectSecure Pacing Lead
Scientific title
Clinical Investigation of the SelectSecure Pacing Lead
Secondary ID [1] 0 0
600
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pacing Lead

Treatment: Devices: Pacing Lead
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Lead and catheter handling characteristics, and lead impedance
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who are in need of an implantable cardioverter defibrillator (ICD).

Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart,
located between the right atrium and right ventricle, which allows blood to flow from the
atrium to the ventricle).

Steroid contraindication

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Canada
State/province [20] 0 0
Kingston
Country [21] 0 0
Canada
State/province [21] 0 0
London
Country [22] 0 0
Canada
State/province [22] 0 0
Ottawa
Country [23] 0 0
Canada
State/province [23] 0 0
Sainte-Foy

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of
an electronic device called a pacemaker. A pacemaker is implanted surgically just under the
skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending
electrical signals (pacing) directly to the heart tissue through flexible wires called leads.
The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe
and effective for both sensing the heart's natural rhythm and pacing the heart when it does
not beat on its own. This lead will be studied in both the right atrium and right ventricle.
A previously market approved Medtronic lead model will serve as a comparison to prove the
safety and effectiveness of the SelectSecure Model.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00266682
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00266682