Permanent Conduction System Pacing vs Native Conduction in Wide QRS with Intermittent Bradycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The multicenter trial is randomized and cross-over, enrolling adults with a pacemaker indication, wide QRS, and predominantly intact AV conduction. It compares conduction system pacing vs native conduction over 12 months, focusing on left ventricular ejection fraction and strain to measure remodeling and dyssynchrony. Primary outcome is the proportion with a ≥10% drop in LVEF or ≥15% drop in GLS at 12 months. Secondary outcomes include functional status, exercise capacity, quality of life, hospitalizations, mortality, arrhythmias, device longevity, and safety. The study uses CSP modalities (LBBP and LVSP) and analyzes subgroups by pacing indication and final CSP modality.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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%

Where it's running

• Hospital Universitario Virgen de las Nieves
  Granada, Andalusia, Spain Recruiting
• Hospital Clínico Universitario Lozano Blesa
  Zaragoza, Aragon, Spain Recruiting
• Hospital Universitari i Politècnic La Fe
  Valencia, Valencia, Spain Recruiting

Study contacts

• Study coordinator: Óscar Cano, MD, PhD
• Email: cano_osc@gva.es
• Phone: +34 961244000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.