Simplifying conduction system pacemaker implantation

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

This observational study will recruit 100 adults who require a pacemaker and divide them into a derivation group (first 50) and a validation group (second 50). All participants will receive conduction system pacemaker implantation while the derivation group undergoes additional testing including ultra-high-frequency surface ECG, invasive electro-anatomical mapping (with a subset having left ventricular activation maps), and noninvasive ECGi with a 252-electrode vest plus CT where used. Echocardiography (transthoracic, transoesophageal, or intracardiac) will also be performed and investigators will record imaging and x-ray features to identify optimal lead locations and improve device signal interpretation. The goal is to define reproducible anatomical and electrical markers that can simplify implantation and device programming for wider clinical use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with a ventricular pacing indication: high grade atrioventricular block and symptomatic trifasicular, bifasicular block or left bundle branch block LBBB for cardiac resynchronisation therapy
2. Adults willing to take part (ages 18 - 100 years old)
3. Able to give consent.

Exclusion Criteria:

1. Unable to give consent
2. Children age \< 18 years and adults \> 100 years old
3. Pregnant patients As per standard of care, female patients of child-bearing age will have a urine pregnancy test prior to their procedure.

Where it's running

• Imperial College Healthcare Trust; Hammersmith Hospital
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Whinnett, BM.BS — Imperial College London, Imperial College Healthcare Trust
• Study coordinator: Akriti Naraen, MBChB
• Email: a.naraen@imperial.ac.uk
• Phone: +91203-31-31000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two pacemaker pacing methods for AV block

  This trial tests whether conduction system (left bundle branch area) pacing or standard right ventricular pacing works better for people with atrioventricular block who need a permanent pacemaker.

  Recruiting at 2 sites University of Tartu · Tallinn, Harju and 1 other locations · NCT07276490

• Postoperative Atrial Pacing in Children After Heart Surgery

  This study tests whether briefly raising a child’s heart rate after heart surgery improves blood flow and oxygen delivery by using temporary atrial pacing at 10 or 20 beats per minute above the child’s natural rate.

  Recruiting Ann & Robert H Lurie Children's Hospital of Chicago · Chicago, Illinois · NCT07852390

• Posterosuperior Bundle Pacing to Reduce Atrial Fibrillation in Sinus Node Dysfunction

  This study tests whether pacing the heart at the posterosuperior bundle reduces atrial fibrillation compared with traditional right atrial appendage pacing in adults needing a pacemaker.

  Recruiting Shanghai Tong Ren Hospital · Anqing, Anhui and 9 other locations · NCT07645066

• Immediate effects of different atrial pacing sites on P-wave characteristics

  This study tests whether pacing the atrium from different sites during pacemaker implantation changes the P-wave on ECG to better reflect natural atrial activation.

  Recruiting Shanghai Tong Ren Hospital · Zunyi, Guizhou and 1 other locations · NCT07603648

• Conduction system pacing vs biventricular pacing for CRT

  This study tests whether pacing the heart’s conduction system (HIS or left bundle) during CRT works better than standard biventricular pacing for people with heart failure.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Aarhus and 4 other locations · NCT07492979

• Pacing decisions guided by risk for pacing-induced heart muscle weakness

  This study tests a risk score to predict pacing-induced cardiomyopathy in adults getting heart rhythm devices, to tailor pacing choices.

  Recruiting at 2 sites Insel Gruppe AG, University Hospital Bern · Canberra, Australian Capital Territory and 12 other locations · NCT07276139

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.