Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conduction

NCT07585799 | Recruiting DMC

• 1 other identifier: MORE-CSP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

Intraventricular conduction delay alone or in combination with AV conduction delay is associated with a dyssynchronous activation of the ventricles and may result in LV function impairment. Conduction system pacing can restore physiologic ventricular activation in the presence of intraventricular and atrioventricular conduction delays. Patients with intraventricular conduction delay alone or in combination with AV conduction delay who have a permanent pacemaker indication due to intermittent bradycardia and have predominantly intact AV conduction may benefit from continuous CSP.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation

  Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation

  12 months

Study Arms (2)

CSP ON

ACTIVE COMPARATOR

Continuous Conduction System Pacing (CSP)

Device: Pacemaker implant

CSP OFF

PLACEBO COMPARATOR

Non active Conduction System Pacing (CSP)

Device: Pacemaker implant

Interventions

Pacemaker implant DEVICE

All patients will receive a ventricular lead in the conduction system (HBP or LBBAP) using conventional implant techniques described elsewhere. The pacemaker device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic PM generators with MVP algorithms will be used during the study. Investigators will use the Medtronic Select Secure 3830 lead for CSP. Acceptable LBBAP threshold should be \<2,5V@0,5ms. Other commercially available stylet driven leads may be used as bail-out strategy only when CSP cannot be achieved with the 3830 lead at the implanting physician discretion. During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA). It is strongly encouraged the designation of a single and experienced CSP implanting physician at each center.

CSP OFF; CSP ON

Eligibility Criteria

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

You may qualify if:

• age \> 18 years
• Any indication for cardiac pacing with an expected VP burden ≤ 10% after 1- month run-in period
• Baseline wide QRS (≥150 ms) with normal PR or QRS ≥ 130 ms + PR≥230 ms
• LVEF≥50%
• Confirmed CSP criteria
• Signed and dated informed consent

You may not qualify if:

• Pregnant woman
• Permanent or long-lasting atrial fibrillation
• Previous PM/ICD
• Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), surgical valve repair or replacement within 90 days prior enrollment
• Moderate-severe valvular heart disease (unrepaired)
• Already included in another clinical study that could confound the results of the present study
• Infiltrative disease or any other genetically or acquired primary myocardial disease
• Life expectancy \< 2 years
• LVEF \<50%

Sponsors & Collaborators

• Óscar Cano Pérez: lead

Study Sites (3)

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, 18014, Spain

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Óscar Cano, MD, PhD

CONTACT

+34 961244000; cano_osc@gva.es

Bernabé López, MD

CONTACT

+34 961244000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: May 14, 2026
• Study Start: July 29, 2025
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

ES (3)