Comparing two pacing methods for treating slow heart rates

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 PROTECT-HF trial is a multi-centre randomized controlled trial designed to compare two different pacing approaches for patients with bradycardia. It will evaluate the traditional right ventricular pacing against a newer physiological pacing method, which includes His and Left bundle area pacing, in a cohort of 2600 patients. Participants will be randomly assigned to one of the two pacing methods, and their outcomes will be assessed at baseline and every six months thereafter. The study aims to provide insights into the effectiveness of these pacing strategies in improving patient outcomes.

Why it matters

Who can join: the full rules

We will recruit patients who are referred for clinically indicated pacemaker implantation

Inclusion Criteria:

1\. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline based ventricular pacing indications:

1. Permanent or intermittent 3rd degree AV block
2. Permanent or intermittent Mobitz type II AV block
3. First Degree AV block with a pacing indication
4. Slow chronic Atrial Fibrillation or Proposed AV node ablation
5. Bifascicular block with a pacing indication
6. Trifascicular block with a pacing indication
7. Wenckebach with a pacing indication

Exclusion Criteria:

1. Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
2. Pregnant women.
3. Unable to provide informed consent.
4. Those with comorbidity leading to a life expectancy \<1year.

Where it's running

• Beacon Hospital
  Dublin, Ireland Recruiting
• Univerisity Medical Centre Ljubljana
  Ljubljana, Slovenia Recruiting
• Aberdeen Royal Infirmary
  Aberdeen, United Kingdom Recruiting
• Queen's Hospital
  Barking, United Kingdom Recruiting
• Good Hope Hospital
  Birmingham, United Kingdom Recruiting
• Queen Elizabeth Hospital
  Birmingham, United Kingdom Recruiting

Study contacts

• Study coordinator: Zachary Whinnett
• Email: z.whinnett@imperial.ac.uk
• Phone: +447749576830

Similar studies

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

• Left bundle branch area pacing with Tendril STS or UltiPace leads

  This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.

  Recruiting at 13 sites Abbott Medical Devices · Rio de Janeiro, Rio de Janeiro and 14 other locations · NCT07217392

• LINEA pacing lead for septal placement in pacemaker patients

  This study tests the safety and performance of a new LINEA cardiac pacing lead for patients getting a new pacemaker with septal placement.

  Recruiting at 14 sites MicroPort CRM · Ghent and 13 other locations · NCT07342608

• Left Bundle Branch Area Pacing vs Right Ventricular Pacing for Atrial Fibrillation Risk in AV Block

  This study tests whether left bundle branch area pacing can lower the chance of developing atrial fibrillation compared with traditional right ventricular pacing in adults with AV block.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06023784

• SPIKE FLOW endocardial pacing lead safety and performance study

  This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.

  Recruiting at 2 sites FIAB SpA · Acquaviva delle Fonti, Bari and 2 other locations · NCT07820072

• Factors Linked to Slow Heart Rate After Pulsed Field Ablation for Atrial Fibrillation

  This study looks for factors that might cause bradycardia during the hospital stay after AF ablation using pulsed field technology.

  Recruiting Wroclaw Medical University · Wroclaw, Lower Silesian Voivodeship · NCT07809347

• Transjugular implantation of a leadless pacemaker (Aveir VR) for ventricular pacing

  This study tests whether placing an Aveir VR leadless pacemaker through the neck vein can safely provide ventricular pacing in adults with bradycardia.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07802119

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.