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Compares treatment options for Bradycardia
Official title "Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
ClinicalTrials.gov ID: NCT05815745
What this study is testing
- What it's testing
- The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- We will recruit patients who are referred for clinically indicated pacemaker implantation 1\. Adults aged over 18 with left ventricular ejection...
- Permanent or intermittent 3rd degree AV block
- Permanent or intermittent Mobitz type II AV block
- First Degree AV block with a pacing indication
- Slow chronic Atrial Fibrillation or Proposed AV node ablation
You likely can't join if
- Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
- Pregnant women.
- Unable to provide informed consent.
- Those with comorbidity leading to a life expectancy \<1year.
See the full eligibility criteria
- We will recruit patients who are referred for clinically indicated pacemaker implantation 1\. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline based...
- Permanent or intermittent 3rd degree AV block
- Permanent or intermittent Mobitz type II AV block
- First Degree AV block with a pacing indication
- Slow chronic Atrial Fibrillation or Proposed AV node ablation
- Bifascicular block with a pacing indication
- Trifascicular block with a pacing indication
- Wenckebach with a pacing indication
- Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
- Pregnant women.
- Unable to provide informed consent.
- Those with comorbidity leading to a life expectancy \<1year.
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, Ireland
- Ljubljana, Slovenia
- Aberdeen, United Kingdom
- Barking, United Kingdom
- Birmingham, United Kingdom
- Bournemouth, United Kingdom
- Brighton, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Chichester, United Kingdom
- Coventry, United Kingdom
- Croydon, United Kingdom
- Edinburgh, United Kingdom
- Fife Keith, United Kingdom
- Gillingham, United Kingdom
- High Wycombe, United Kingdom
- Larbert, United Kingdom
- Leeds, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, Ireland; Ljubljana, Slovenia; Aberdeen, United Kingdom; Barking, United Kingdom; Birmingham, United Kingdom; Bournemouth, United Kingdom and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.