RAFT - Pace &Ablate

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHabib Khan

About this trial

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.

A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with permanent AF/persistent AF (in AF)

Patients with NYHA Class II -IVa HF symptoms

for those < 75 years of age with an NT-proBNP of ≥ 600 ng/L

for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year

Disqualifiers

In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days

Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year

Acute coronary syndrome <4 weeks or coronary revascularization <3months

Unable or unwilling to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pace and Ablate

    Device

    Conduction System Pacing (CSP) followed by AtrioVentricular Node Ablation (AVNA)

  • Medication

    Drug

    Optimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Pharmacological TherapyActive comparator 1 intervention
Group B: P&A-CSPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Winratio

Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL.

Time frame
12 months

Secondary outcomes

1

All-cause mortality

Mortality from any cause within the 12 month of follow up period

Time frame
12 months
2

Cardiovascular mortality

Mortality attributed to cardiovascular causes within 12 month follow up period

Time frame
12 months
3

Number of heart failure events

Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay

Time frame
12 months
4

All-cause hospitalization

ER admission or overnight stay

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Habib Khan

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution