Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The recent development and market introduction of small diameter implantable defibrillation leads able to deliver left bundle branch area pacing (LBBAP) has opened the possibility of achieving cardiac resynchronization therapy (CRT) using a single- or dual-chamber implantable-cardioverter defibrillator (ICD). This approach may reduce the number of intracardiac leads required and, consequently, has the potential to lower both procedural and long-term complication rates. However, the integration of these leads into currently recommended CRT strategies remains hypothetical. The FORGE CSP registry will prospectively enroll patients with an indication for CRT in whom implantation of a LBBAP ICD lead is attempted.
Detailed description
The FORGE CSP Registry is a prospective, multicentre and nationwide, post-approval registry, including consecutive patients with an indication for CRT and in whom implantation of a LBBAP ICD lead is attempted as a first line strategy.
The primary objective of this registry is to measure the proportion of patients who achieve effective CRT solely through the use of a LBBAP ICD lead (plus right atrial lead if appropriate).
The secondary objectives of this registry are: (1) to assess the feasibility of the LBBAP ICD lead implantation (regarding LBBAP validated electrophysiologic criteria) and the associated learning curve; (2) to evaluate the incidence of implantation of a third lead, namely a left ventricular lead positioned in the coronary sinus, in combination with the LBBAP ICD lead (LOT-CRT); (3) to assess the risk of complications related to the use of the LBBAP ICD lead, including its impact on tricuspid valve function, the risk of lead dislodgement, and other procedure- or device-related complications; (4) to evaluate de cost-effectiveness of CRT using LBBAP ICD lead, compared with conventional CRT; (5) and to compare CRT response in LBBAP ICD lead recipients, versus historical cohort of conventional CRT.
Primary outcome measures
- LBBAP ICD lead CRT efficacy [Time frame: 0 - 3 Months]
Secondary outcome measures (4)
- LBBAP ICD lead implantation feasibility [Time frame: Procedural]
- LOT-CRT utilization [Time frame: Procedural]
- Safety of LBBAP ICD lead [Time frame: 0 - 3 Months]
- Cost-effectiveness [Time frame: Procedural]
Eligibility criteria
Inclusion criteria
- age > 18-year-old
- indication for CRT according to current ESC/EHRA guidelines
- first-line LBBAP ICD lead implantation attempted
- national insurance coverage
Exclusion criteria
- pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Caen University Hospital — Caen
Publications
- Vijayaraman P, Liu X, Denman R, Schloss EJ, Whinnett ZI, Kron J, Jastrzebski M, Zakaib JS, Abhayaratna WP, Philippon F, Afzal MR, Pokharel P, Burrell J, Tanner J, Geelen T, Platner ML, Butler K, Mason PK, Crossley GH; LEADR LBBAP Trial Investigators. Safety and performance of a novel defibrillation lead for left bundle branch area placement: Primary results of the LEADR LBBAP clinical trial. Heart PMID 41110529
- Crossley GH 3rd, Sanders P, Hansky B, De Filippo P, Shah MJ, Shoda M, Khelae SK, Richardson TD, Philippon F, Zakaib JS, Tse HF, Sholevar DP, Stellbrink C, Pathak RK, Milasinovic G, Chinitz JS, Tsang B, West MB, Ramza BM, Han X, Bozorgnia B, Carta R, Geelen T, Himes AK, Platner ML, Thompson AE, Mason PK; Lead EvaluAtion for Defibrillation and Reliability Trial Investigators. Safety, efficacy, and r PMID 38762820
- Sanders P, Mason PK, Hansky B, De Filippo P, Shah MJ, Sholevar DP, Zakaib JS, Philippon F, Tsang B, Pathak RK, Richardson TD, Friedman M, Schaller RD, Anguera I, Mihalcz A, Bozorgnia B, Thompson AE, Arias K, Maus B, Bounds C, Crossley GH. Sensing and detection performance of the novel, small-diameter OmniaSecure defibrillation lead: in-depth analysis from the LEADR trial. Europace. 2025 Mar 28;27( PMID 40127675
- Crossley GH 3rd, Mason PK, Hansky B, De Filippo P, Shah MJ, Philippon F, Sholevar D, Richardson TD, West MB, Dinerman J, Dawson J, Himes A, Severseike L, Thompson AE, Sanders P. High predicted durability for the novel small-diameter OmniaSecure defibrillation lead. Heart Rhythm. 2025 Feb;22(2):302-310. doi: 10.1016/j.hrthm.2024.09.005. Epub 2024 Sep 26. PMID 39341436
- Crossley GH, Sanders P, Hansky B, De Filippo P, Shah MJ, Khelae SK, Richardson TD, Philippon F, Zakaib JS, Geelen T, Arias K, Maus B, Mason PK; Lead EvaluAtion for Defibrillation and Reliability Trial Investigators. Safety and Efficacy of the Novel OmniaSecure Defibrillation Lead Through Long-Term Follow-Up: Final Results From the LEADR Trial. Circ Arrhythm Electrophysiol. 2026 Jan;19(1):e014424. PMID 41222500
Identifiers
NCT: NCT07406737 · 2026-RYTHMO-01