ASCEND CSP IDE Study

NCT06830746 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10549
• Study Type: interventional
• Target: 414
• Locations: 10 countries
• Sites: 37

Brief 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. 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

Keywords

ICD; CRT-D; LBBAP; conduction system pacing; lead

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  at implant

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: LBBAP Implant with a CSP ICD Lead

Interventions

LBBAP Implant with a CSP ICD Lead DEVICE

Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (37)

Heart Center Research LLC

Huntsville, Alabama, 35801, United States

Location

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Premier Cardiology, Inc.

Newport Beach, California, 92663, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

The Prince Charles Hospital

Chermside, Queensland, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Monash Health

Clayton, Victoria, Australia

Location

MUHC- Montreal General Hospital

Montreal, H3G 1A4, Canada

Location

CHRU Hopital de Pontchaillou

Rennes, Brittan, 35033, France

Location

CHU Trousseau

Chambray-lès-Tours, Centre-Val de Loire, 37170, France

Location

Hôpital Pitié Salpetrière

Paris, Ile, 75013, France

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Max Super Specialty Hospital

New Delhi, National Capital Territory of Delhi, 110017, India

Location

Sree Chitra Tirunal Institute for Medical Sciences & tech.

Trivandrum, New Delhi, 695-011, India

Location

Velammal Medical College Hospital

Madurai, Tmlnadu, 625009, India

Location

Ospedale S.S. Annunziata

Taranto, Apulia, 74100, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombard, 20162, Italy

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Changi General Hospital

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 17, 2025
• Study Start: April 11, 2025
• Primary Completion: January 29, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

ES (2); SG (3); FR (3); HK (2); CH (1); IN (3); IT (2); US (16); AU (4); CA (1)