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Trial registered on ANZCTR


Registration number
ACTRN12608000593336
Ethics application status
Approved
Date submitted
22/10/2008
Date registered
21/11/2008
Date last updated
21/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pacing Alternate Sites using SelectSecure (PASSES Study): To assess the ease of implant in targeting alternate pacing sites with a catheter delivered lead compared with the stylet lead.
Scientific title
The PASSES Study: Assessing the implant success rates and the clinical and economic benefits for implanting dual chamber pacemaker and leads at alternate pacing locations with the SelectSecure lead.
Universal Trial Number (UTN)
Trial acronym
The PASSES Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dual Chamber pacemakers 3857 0
Condition category
Condition code
Cardiovascular 4052 4052 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implantation of a dual chamber pacemaker and leads (catheter delivered or stylet) at alternate pacing site (Right Ventricular Outflow Tract (RVOT) and Right Atrial septum). This is a permanent pacemaker implant involving a one-off surgical procedure.
Intervention code [1] 3582 0
Treatment: Devices
Comparator / control treatment
Implanation of a dual chamber pacemaker and stylet leads at traditional pacing location (Atrial appendage and Right Ventricular (RV) Apex)
Control group
Active

Outcomes
Primary outcome [1] 4950 0
Implant success rate measured with Fluoroscopy images, 12 lead paced Echocardiogram (ECG) and Physician assessment for position verification.
Timepoint [1] 4950 0
Implant, Pre-hospital discharge, 3 months
Secondary outcome [1] 8346 0
Health Care Utilisation collected from medical records and a Patient Diary.
Timepoint [1] 8346 0
Pre-hospital Discharge (PHD), 3 months, 6 months, 6 monthly for up to 10 years
Secondary outcome [2] 8347 0
Patient Symptoms (questions asked to patients by Physician at follow-up visits), and Adverse events. Eg. Implant complications, lead performance outside expectation such as dislodgement, loss of capture, threshols and sendsing concerns. These will be collected at follow up visits by testing the electrical performance of the leads and reviewing the device diagnostics.
Timepoint [2] 8347 0
PHD, 3 months, 6 months, 6 monthly for up to 10 years
Secondary outcome [3] 8348 0
Atrial Fibrillation and Heart failure burden measured by Physician assessment of Heart Failure (New York Heart Association Classification) and Pacemaker diagnostics for Atrial Fibrillation burden .
Timepoint [3] 8348 0
PHD, 3 months, 6 months, 6 monthly for up to 10 years

Eligibility
Key inclusion criteria
Patient has standard indications for first implantation of a dual chamber Brady Pacemaker
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous pacemaker implant and
patients with mechanical right heart valves

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation stratified per investigator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
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 postcode(s) [1] 1204 0
3550
Recruitment postcode(s) [2] 1205 0
3121
Recruitment postcode(s) [3] 1206 0
6009
Recruitment postcode(s) [4] 1207 0
2310
Recruitment postcode(s) [5] 1208 0
5000
Recruitment postcode(s) [6] 1209 0
4000
Recruitment postcode(s) [7] 1210 0
2076
Recruitment postcode(s) [8] 1211 0
3084
Recruitment outside Australia
Country [1] 1288 0
New Zealand
State/province [1] 1288 0
Wellington

Funding & Sponsors
Funding source category [1] 4034 0
Commercial sector/Industry
Name [1] 4034 0
Medtronic Australasia Pty Ltd
Address [1] 4034 0
97 Waterloo Road
North Ryde, NSW 2113
Country [1] 4034 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Australasia Pty Ltd
Address
97 Waterloo Road
North Ryde, NSW 2113
Country
Australia
Secondary sponsor category [1] 3627 0
None
Name [1] 3627 0
Address [1] 3627 0
Country [1] 3627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6118 0
Uniting Health Care Human Research Ethics Committee
Ethics committee address [1] 6118 0
The Wesley Hospital, PO Box 499, Auchenflower, Qld, 4066
Ethics committee country [1] 6118 0
Australia
Date submitted for ethics approval [1] 6118 0
Approval date [1] 6118 0
18/05/2005
Ethics approval number [1] 6118 0
Ethics committee name [2] 6119 0
Wakefield Hospital HREC
Ethics committee address [2] 6119 0
300 Wakefield Street, Adelaide SA 5000
Ethics committee country [2] 6119 0
Australia
Date submitted for ethics approval [2] 6119 0
Approval date [2] 6119 0
05/08/2004
Ethics approval number [2] 6119 0

Summary
Brief summary
Medical evidence suggests that the right ventricular (RV) apex and right atrial (RA) appendage may be suboptimal lead locations for providing chronically effective pacing therapy. Over recent years alternate pacing sites, or ‘selective sites’, have been proposed and evaluated. These are sites other than the traditional Atrial Appendage and RV Apex pacing. Such sites are suggested to reduce ventricular dysfunction, atrial arrhythmias, and influence morbidity resulting from asynchronous Left Ventricular (LV) activation associated with traditional RV apex pacing. The Medtronic SelectSecure Deflectable Catheter Delivered Lead System was developed to assist physicians implanting a pacing lead in an RV or RA selective site such as the RVOT or the ventricular septum, the Bachman bundle area or the atrial septum.

PASSES is a prospective, randomised, multicenter clinical trial to assess the ease of implant in targeting alternate pacing sites with a catheter delivered lead compared with the stylet lead. The chronic aspect of the study will enable analysis of the long-term lead performance and will provide a first estimation of economic benefits for pacing with a new therapy and tool. This study compares the novel approach of new therapy of pacing selective sites with new tools to the traditional pacing therapy and tools.

During the follow-up period information will be collected on lead performance (electrical and clinical data), adverse events, health care utilization, and progression of HF and AF. This is expected to provide information on the long-term lead performance, and the clinical and economic benefits for implanting alternate sites with the SelectSecure lead.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29061 0
Address 29061 0
Country 29061 0
Phone 29061 0
Fax 29061 0
Email 29061 0
Contact person for public queries
Name 12218 0
Arianne Lee
Address 12218 0
97 Waterloo Road, North Ryde NSW 2113
Country 12218 0
Australia
Phone 12218 0
+61 2 9857 9086
Fax 12218 0
Email 12218 0
arianne.lee@medtronic.com
Contact person for scientific queries
Name 3146 0
Arianne Lee
Address 3146 0
97 Waterloo Road, North Ryde NSW 2113
Country 3146 0
Australia
Phone 3146 0
+61 2 9857 9086
Fax 3146 0
Email 3146 0
arianne.lee@medtronic.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary