Cardiac Resynchronization TherapyFORGE CSPNCT07406737
Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
An observational study of Cardiac Resynchronization Therapy and Left Bundle Branch Area Pacing, run by University Hospital, Caen at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2026to 1 Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age > 18-year-old
- indication for CRT according to current ESC/EHRA guidelines
- first-line LBBAP ICD lead implantation attempted
- national insurance coverage
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0 - 3 Months
Secondary outcomes (4)
LBBAP ICD lead implantation feasibility
Incidence of successful LBBAP ICD lead implantation (defined by LBBAP ECG validated criteria)
Measured: Procedural
LOT-CRT utilization
Incidence of coronary sinus left ventricular lead implantation (in addition to LBBAP ICD lead)
Measured: Procedural
Safety of LBBAP ICD lead
Incidence of ICD lead micro or macro-dislodgment Incidence of de novo tricuspid regurgitation (grade > or = 3) Incidence of loss of CRT (based on LBBAP validated ECG criteria)
Measured: 0 - 3 Months
Cost-effectiveness
Comparaison of device-associated costs in LBBAP ICD lead recipients and conventional CRT recipients.
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre OLLITRAULT, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406737
- Sponsor's protocol ID
- 2026-RYTHMO-01
- Acronym
- FORGE CSP
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Rhythm. 2025 Oct 17:S1547-5271(25)02981-9. doi: 10.1016/j.hrthm.2025.10.028. Online ahead of print.
PubMed 41110529Crossley 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.
PubMed 38762820Sanders 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.
PubMed 40127675Crossley 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.
PubMed 39341436Crossley 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.
PubMed 41222500
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
- ClinicalTrials.gov ID
- NCT07406737
- Acronym / sponsor ID
- FORGE CSP / 2026-RYTHMO-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- age > 18-year-old
- indication for CRT according to current ESC/EHRA guidelines
- first-line LBBAP ICD lead implantation attempted
- national insurance coverage
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LBBAP ICD lead CRT efficacy
Time frame: 0 - 3 Months
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).
4 secondary outcomes
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
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 12 Feb 2026.
- Background: PubMed 41110529Vijayaraman 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.
- Background: PubMed 38762820Crossley 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.
- Background: PubMed 40127675Sanders 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.
- Background: PubMed 39341436Crossley 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.
- Background: PubMed 41222500Crossley 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Resynchronization Therapy and Left Bundle Branch Area Pacing, run by University Hospital, Caen at 1 site in France.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Pierre OLLITRAULT, MD (+330231063106, ollitrault-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LBBAP ICD lead CRT efficacy (time frame: 0 - 3 Months). 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 NCT07406737, which also lists 5 linked publications.
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 12 Feb 2026.