Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing

NCT07406737 | Not Yet Recruiting DMC

• 1 other identifier: 2026-RYTHMO-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Resynchronization Therapy; Left Bundle Branch Area Pacing

Outcome Measures

Primary Outcomes (1)

• LBBAP ICD lead CRT efficacy

  Proportion of patients with an effective CRT (defined by LBBAP validated ECG criteria) using solely the LBBAP ICD lead (plus right atrial lead if appropriate).

  0 - 3 Months

Secondary Outcomes (4)

• LBBAP ICD lead implantation feasibility

  Procedural

• LOT-CRT utilization

  Procedural

• Safety of LBBAP ICD lead

  0 - 3 Months

• Cost-effectiveness

  Procedural

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with a validated CRT indication for whom the implantation of a LBBAP ICD lead in attempted as a first-line strategy.

You may qualify if:

• age \> 18-year-old
• indication for CRT according to current ESC/EHRA guidelines
• first-line LBBAP ICD lead implantation attempted
• national insurance coverage

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

Related Publications (5)

• 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 Rhythm. 2025 Oct 17:S1547-5271(25)02981-9. doi: 10.1016/j.hrthm.2025.10.028. Online ahead of print.

  PMID: 41110529 BACKGROUND

• 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 reliability evaluation ofa novel small-diameter defibrillation lead: Global LEADR pivotal trial results. Heart Rhythm. 2024 Oct;21(10):1914-1922. doi: 10.1016/j.hrthm.2024.04.067. Epub 2024 May 17.

  PMID: 38762820 BACKGROUND

• 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(4):euaf062. doi: 10.1093/europace/euaf062.

  PMID: 40127675 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1161/CIRCEP.125.014424. Epub 2025 Nov 12.

  PMID: 41222500 BACKGROUND

Central Study Contacts

Pierre OLLITRAULT, MD

CONTACT

+330231063106; ollitrault-p@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)