Pacemaker Techniques for Atrial Fibrillation

(RAFT-P&A RCT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Severe pulmonary diseases, Hypertrophic cardiomyopathy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial compares a new pacemaker technique to optimal medical therapy, it's possible that you may need to continue your current heart-related medications.

What data supports the effectiveness of the treatment Pacemaker Techniques for Atrial Fibrillation?

Research shows that using a pacemaker with AV node ablation is effective for controlling heart rate in patients with atrial fibrillation, especially when medication doesn't work. This approach is particularly beneficial for older patients and can improve symptoms and quality of life.

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Is the pacemaker technique for atrial fibrillation safe?

Pacemaker implantation with atrioventricular node ablation is generally considered safe, but there are concerns about dependency on the pacemaker and potential issues if the pacemaker fails. Some studies suggest alternative pacing sites, like the His bundle, to reduce long-term adverse effects.

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How is the 'Pace and Ablate' treatment for atrial fibrillation different from other treatments?

The 'Pace and Ablate' treatment for atrial fibrillation is unique because it combines the ablation (removal or destruction) of the atrioventricular (AV) node with the implantation of a pacemaker, providing a reliable way to control heart rhythm, especially in patients who do not respond to other treatments. This approach is particularly beneficial for elderly patients or those with heart failure, as it offers a more physiological pacing method through conduction system pacing, which can improve heart function.

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Eligibility Criteria

This trial is for older adults with atrial fibrillation, a type of irregular heartbeat that can cause symptoms like skipped beats or shortness of breath. It's specifically for those who struggle to tolerate standard medications due to side effects and may benefit from a pacemaker combined with AV node ablation.

Inclusion Criteria

NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year despite guideline-driven medical therapy for HF of at least 3 months

I have long-term or permanent atrial fibrillation.

I experience moderate to severe heart failure symptoms.

Exclusion Criteria

I've needed intensive care or strong IV heart medication in the last 4 days.

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

I do not have severe lung conditions like cor pulmonale or high blood pressure in the lungs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pharmacological therapy or P&A-CSP. For P&A-CSP, CSP and ICD are provided if LVEF ≤35%, and catheter AVNA is performed within 4 weeks.

4 weeks

Follow-up

Participants are monitored for cardiovascular mortality, cognitive assessment, and other health outcomes.

12 months

Participant Groups

The study compares two types of pacemakers: BiVP, which stimulates both sides of the heart, and CSP, a newer method with fewer leads. It also tests if these 'pace and ablate' strategies are better than just using drugs to manage heart rate in patients with AF.

Group I: P&A-CSP Experimental Treatment 1 Intervention

Patients randomized to P\&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.

Group II: Pharmacological Therapy Active Control 1 Intervention

Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35%

Pace and Ablate is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Pace and Ablate for:

• Symptomatic atrial fibrillation refractory to medical therapy

🇺🇸 Approved in United States as Pace and Ablate for:

• Symptomatic atrial fibrillation refractory to medical therapy

🇨🇦 Approved in Canada as Pace and Ablate for:

• Symptomatic atrial fibrillation refractory to medical therapy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

London Health Sciences Centre - University Hospital London, Canada

London Health Sciences Research London, Canada

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's Lead Sponsor

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

Lawson Health Research Institute Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of pacemaker dependence in patients on ablate and pace therapy for atrial fibrillation. [2010] In patients with atrial fibrillation (AF) and uncontrolled ventricular rate, radiofrequency (RF) ablation of the atrioventricular (AV) node and pacemaker (PM) implantation (ablate and pace) is a valid therapeutic approach, especially in elderly patients. The aim of our study was to evaluate the PM dependence and the incidence of correlated clinical phenomena in a patients population with AV block induced by RF ablation of the AV junction.

2. United States pubmed.ncbi.nlm.nih.gov

Just how stable are escape rhythms after atrioventricular junction ablation? [2010] Atrioventricular (AV) node ablation with implantation of a permanent pacemaker is an established mode of therapy in the treatment of atrial fibrillation. However, concern exists regarding subsequent dependency on an entirely paced rhythm and the possible sequela of unheralded pacemaker failure. Data regarding escape rhythm lability, an important feature of pacemaker dependency, are limited.

3. United States pubmed.ncbi.nlm.nih.gov

Direct His bundle pacing post AVN ablation. [2009] Atrioventricular nodal (AVN) ablation with concomitant pacemaker implantation is one of the strategies that reduce symptoms in patients with atrial fibrillation (AF). However, the long-term adverse effects of right ventricular (RV) apical pacing have led to the search for alternating sites of pacing. Biventricular pacing produces a significant improvement in functional capacity over RV pacing in patients undergoing AVN ablation. Another alternative site for pacing is direct His bundle to reduce the adverse outcome of RV pacing. Here, we present a case of direct His bundle pacing using steerable lead delivery system in a patient with symptomatic paroxysmal AF with concurrent AVN ablation.

4. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up in AV junction ablation via the SVC in patients undergoing concurrent device implantation: a single center experience. [2015] Ablation of the atrioventricular junction (AVJ) combined with pacemaker implantation (the "ablate and pace" approach) has been an effective treatment strategy for patients with atrial fibrillation (AF) when rate control is the goal of therapy and when rapid ventricular rates during AF is refractory to pharmacologic therapy.

5. United States pubmed.ncbi.nlm.nih.gov

Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation. [2019] Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs).

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Left Bundle Branch Area Pacing Combined with Atrioventricular Node Ablation in Atrial Fibrillation Patients with Heart Failure. [2022] Pacemaker implantation combined with atrioventricular node ablation (AVNA) could be a practical choice for atrial fibrillation (AF) patients with heart failure (HF). Left bundle branch area pacing (LBBaP) has been widely reported.

7. England pubmed.ncbi.nlm.nih.gov

Role of conduction system pacing in ablate and pace strategies for atrial fibrillation. [2023] With the advent of conduction system pacing, the threshold for performing 'ablate and pace' procedures for atrial fibrillation has gone down markedly in many centres due to the ability to provide a simple and physiological means of pacing the ventricles. This article reviews the technical considerations for this strategy as well as the current evidence, recognized indications, and future perspectives.

8. Netherlands pubmed.ncbi.nlm.nih.gov

Atrioventricular node ablation and pacing for atrial tachyarrhythmias: A meta-analysis of postoperative outcomes. [2022] Atrioventricular node ablation (AVNA) and pacemaker (PM) is performed in symptomatic atrial fibrillation (AF) unresponsive to medical treatment and percutaneous ablation. This meta-analysis evaluated results after AVNA and PM.