Heart FailureASCEND CSP IDENCT06830746
ASCEND CSP IDE Study
A study testing LBBAP Implant with a CSP ICD Lead in people with Heart Failure and Ventricular Arrythmia, run by Abbott Medical Devices at 37 sites in 10 countries.
Trial summary
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Ventricular Arrythmia
- What is being tested?
- LBBAP Implant with a CSP ICD Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 37 sitesin 10 countries
- Study dates
- 11 Apr 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
- de novo Abbott ICD system implant (single or dual chamber)
- 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)
- Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
- 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.
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
- 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.
Who cannot join
- Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent
- 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
- 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
- Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
- Subject has a life expectancy of less than 12 months
- Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve)
Show all 27Show fewer
- Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate.
- 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
- Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads
- Subject has any evidence of active infection or undergoing treatment for an infection
- Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
- Subject has moderate or severe aortic stenosis
- 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
- Subject has end-stage renal disease
- Subject has NYHA IV classification
- 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
- Subject has had previously extracted leads
- Subject has had an LV Assist Device
- Subject has had a failed LBBAP lead implant
- Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):
- Subject has pre-existing or suspected pneumothorax during implant
- Subject has current known intracardiac left atrial or Left Ventricular thrombus
- Subject has severe proximal three-vessel or left main coronary artery disease without revascularization
- Subject has Ejection Fraction less than 20%
- Subject has recent stroke or transient ischemic attack (within the last 6 months)
- Subject has known inadequate external defibrillation
- Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
United States16 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Erlanger Medical Center
Chattanooga, Tennessee, 37403
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Medical City Dallas Hospital
Dallas, Texas, 75230
Geisinger Medical Center
Danville, Pennsylvania, 17822
Heart Center Research LLC
Huntsville, Alabama, 35801
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
Premier Cardiology, Inc.
Newport Beach, California, 92663
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
AdventHealth Orlando
Orlando, Florida, 32803
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92103
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia
The Prince Charles Hospital
Chermside, Queensland
Monash Health
Clayton, Victoria
Princess Alexandra Hospital
Woolloongabba, Queensland
France3 sites
CHU Trousseau
Chambray-lès-Tours, Centre-Val de Loire, 37170
Hôpital Pitié Salpetrière
Paris, Ile, 75013
CHRU Hopital de Pontchaillou
Rennes, Brittan, 35033
India3 sites
Velammal Medical College Hospital
Madurai, Tmlnadu, 625009
Max Super Specialty Hospital
New Delhi, National Capital Territory of Delhi, 110017
Sree Chitra Tirunal Institute for Medical Sciences & tech.
Trivandrum, New Delhi, 695-011
Singapore3 sites
National Heart Centre Singapore
Singapore, 169609
Changi General Hospital
Singapore
Tan Tock Seng Hospital
Singapore
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Italy2 sites
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombard, 20162
Ospedale S.S. Annunziata
Taranto, Apulia, 74100
Spain2 sites
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitari i Politècnic La Fe
Valencia, 46026
About this study
Official title: A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.
- Conditions
- Heart Failure, Ventricular Arrythmia
- Being tested
- LBBAP Implant with a CSP ICD Lead
- Keywords
- ICD, CRT-D, LBBAP, conduction system pacing, lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBBAP Implant with a CSP ICD LeadDevice
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing Receives: Device: LBBAP Implant with a CSP ICD Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
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
Measured: 3 months post-implant
Primary Effectiveness Endpoint 1
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
Measured: 3-months post-implant
Primary Effectiveness Endpoint 2
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
Measured: at implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start11 Apr 2025
- Primary completion29 Jan 2026
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830746
- Sponsor's protocol ID
- ABT-CIP-10549
- Acronym
- ASCEND CSP IDE
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schaller RD, Sanders P, Joza J, Zimetbaum P, Birgersdotter-Green U, Tung R, Singh B, Tam MTK, Thomaides A, Nair D, Leclercq C, Vijayaraman P, Hadadi CA, Wiley J, Ganz L, Feng L, Johnson G, Ryu K, Shaw R, Charan V, Lee K, Burri H; ASCEND CSP Investigators. Safety and performance of a novel ICD lead for left bundle branch area pacing: Results from the ASCEND CSP trial. Heart Rhythm. 2026 Aug;23(8):1813-1824. doi: 10.1016/j.hrthm.2026.03.1939. Epub 2026 Apr 25.
PubMed 42033435
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study
- ClinicalTrials.gov ID
- NCT06830746
- Acronym / sponsor ID
- ASCEND CSP IDE / ABT-CIP-10549
- Conditions
- Heart Failure, Ventricular Arrythmia
- Keywords
- ICD, CRT-D, LBBAP, conduction system pacing, lead
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- May 2028 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: LBBAP Implant with a CSP ICD LeadSubjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
- Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
- 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.
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
- 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.
Key exclusion criteria (27 listed)
- Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent
- 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
- 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
- Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
- Subject has a life expectancy of less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBBAP Implant with a CSP ICD LeadRequired electrical testing for pacing, sensing, impedance and defibrillation will be completed | Device | Treatment |
Primary outcome
Primary Safety Endpoint
Time frame: 3 months post-implant
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
Primary Effectiveness Endpoint 1
Time frame: 3-months post-implant
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
Primary Effectiveness Endpoint 2
Time frame: at implant
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 42033435Schaller RD, Sanders P, Joza J, Zimetbaum P, Birgersdotter-Green U, Tung R, Singh B, Tam MTK, Thomaides A, Nair D, Leclercq C, Vijayaraman P, Hadadi CA, Wiley J, Ganz L, Feng L, Johnson G, Ryu K, Shaw R, Charan V, Lee K, Burri H; ASCEND CSP Investigators. Safety and performance of a novel ICD lead for left bundle branch area pacing: Results from the ASCEND CSP trial. Heart Rhythm. 2026 Aug;23(8):1813-1824. doi: 10.1016/j.hrthm.2026.03.1939. Epub 2026 Apr 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LBBAP Implant with a CSP ICD Lead in people with Heart Failure and Ventricular Arrythmia, run by Abbott Medical Devices at 37 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Australia, France, India, Singapore and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 3 months post-implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.