NCT07279870 RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease
| NCT ID | NCT07279870 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Atrioventricular Block |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,260 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,260 participants in total. It began in 2025-12-03 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study objective is to assess whether stimulation of the conduction system reduces cardiac decompensation events in patient follow-up, and how applicable this is in clinical practice and also to determine the impact of the studied interventions in terms of quality of life and cost-effectiveness for the treatment of patients with atrioventricular block. 1260 adult patients who are candidates for pacemaker implantation for the treatment of atrioventricular conduction disease will be randomised to stimulation of the conduction system or to the conventional stimulation.
Eligibility Criteria
Inclusion Criteria: * Adult patients with AV block in either sinus rhythm (SR) or permanent atrial tachycardia/atrial fibrillation (AT/AF), or with slow AV conduction during AT/AF, or undergoing AV node ablation + ventricular stimulation * male and female * acquired informed consent Exclusion Criteria: * Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT) * Ejection Fraction \< 35% * Life expectancy \< 2 years * Participation in another clinical trial which might impact on the study outcome * Pregnancy, except as "In the event of an ongoing pregnancy, the doctor and patient will jointly assess, on a case-by-case basis and in the best interests of the patient, whether to propose participation in the study (random assignment to one of the two stimulation techniques) or to proceed as per clinical practice (assignment to one of the two stimulation techniques by the doctor). A screening log file of all eligible patients will be recorded, detailing the reason/s for non-randomization."
Contact & Investigator
Mauro Biffi, MD
PRINCIPAL INVESTIGATOR
IRCCS AOUBO Policlinico di Sant'Orsola
Frequently Asked Questions
Who can join the NCT07279870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrioventricular Block. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07279870 currently recruiting?
Yes, NCT07279870 is actively recruiting participants. Contact the research team at mauro.biffi@aosp.bo.it for enrollment information.
Where is the NCT07279870 trial being conducted?
This trial is being conducted at Bari, Italy, Bologna, Italy, Catania, Italy, Ferrara, Italy and 10 additional locations.
Who is sponsoring the NCT07279870 clinical trial?
NCT07279870 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Mauro Biffi, MD at IRCCS AOUBO Policlinico di Sant'Orsola. The trial plans to enroll 1,260 participants.