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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06830746




Registration number
NCT06830746
Ethics application status
Date submitted
12/02/2025
Date registered
17/02/2025
Date last updated
29/06/2025

Titles & IDs
Public title
ASCEND CSP IDE Study
Scientific title
A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study
Secondary ID [1] 0 0
ABT-CIP-10549
Universal Trial Number (UTN)
Trial acronym
ASCEND CSP IDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Ventricular Arrythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - LBBAP Implant with a CSP ICD Lead

Experimental: Treatment - Subjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing


Treatment: Devices: LBBAP Implant with a CSP ICD Lead
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint
Assessment method [1] 0 0
Freedom from CSP ICD Lead-related Serious Adverse Device Effects (SADEs) through 3 months post-implant for subjects in which the CSP ICD Lead implant was attempted
Timepoint [1] 0 0
3 months post-implant
Primary outcome [2] 0 0
Primary Effectiveness Endpoint 1
Assessment method [2] 0 0
3-month composite success rate of acceptable pacing capture thresholds and R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA
Timepoint [2] 0 0
3-months post-implant
Primary outcome [3] 0 0
Primary Effectiveness Endpoint 2
Assessment method [3] 0 0
Success rate of the defibrillation testing at implant in the subjects who complete the defibrillation test with the CSP ICD Lead implanted at the LBBA
Timepoint [3] 0 0
at implant

Eligibility
Key inclusion criteria
1. Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:

1. de novo Abbott ICD system implant (single or dual chamber)
2. de novo Abbott CRT-D system implant and is intended to also undergo left ventricle coronary sinus lead implant (for patients indicated for CRT-D according to locally approved indications)
2. Subject is = 18 years of age or age of legal consent, whichever age is greater.
3. Subject is willing to undergo implant defibrillation testing if requested. Subjects with AF in whom defibrillation testing is required must have been on or willing to be on uninterrupted anticoagulation therapy before, during, and after the implant procedure.
4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent
2. Subject has had recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
3. Subject has had any other therapeutic cardiovascular procedure (such as transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent or planned within 3 months following consent
4. Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
5. Subject has a life expectancy of less than 12 months
6. Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve)
7. Subject is contraindicated for =1mg Dexamethasone sodium phosphate.
8. Subject is pregnant or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
9. Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads
10. Subject has any evidence of active infection or undergoing treatment for an infection
11. Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
12. Subject has moderate or severe aortic stenosis
13. Subject has ventricular septal defect (VSD) or had prior surgery on the interventricular septum that could impact LBBAP implant, such as septal myomectomy, ethanol septal ablation, VSD repair, etc
14. Subject has end-stage renal disease
15. Subject has NYHA IV classification
16. Subject has undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
17. Subject has had previously extracted leads
18. Subject has had an LV Assist Device
19. Subject has had a failed LBBAP lead implant

Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):

1. Subject has pre-existing or suspected pneumothorax during implant
2. Subject has current known intracardiac left atrial or Left Ventricular thrombus
3. Subject has severe proximal three-vessel or left main coronary artery disease without revascularization
4. Subject has Ejection Fraction less than 20%
5. Subject has recent stroke or transient ischemic attack (within the last 6 months)
6. Subject has known inadequate external defibrillation
7. Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
414
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06830746