Pacemaker Techniques for Atrial Fibrillation

(RAFT-P&A RCT Trial)

Recruiting at 1 trial location

Overseen By Abbie Pardo

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage atrial fibrillation (AF), a condition characterized by an irregular heartbeat. The researchers aim to determine if Conduction System Pacing (CSP), combined with a procedure to control heart rhythm, is more effective than medication alone. The trial will compare CSP with the standard medicine-based approach to assess effectiveness for AF patients. Individuals who have had AF for a while, experience heart failure symptoms affecting daily life, and have been on heart failure medications for at least three months may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance AF management.

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 prior data suggests that these pacemaker techniques are safe for treating atrial fibrillation?

Research has shown that the "Pace and Ablate" treatment, which involves implanting a pacemaker and intentionally damaging the AV node, is generally effective and safe. However, complications can include worsening heart failure, permanent irregular heartbeats, and a higher risk of sudden death.

Recent studies have explored using a special pacemaker that stimulates both sides of the heart simultaneously. This approach aims to control the heart's rhythm more effectively and might reduce some risks. However, these devices may not always be reliable in the long term.

Overall, while this treatment can help manage atrial fibrillation (an irregular heartbeat), it is crucial to consider the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these pacemaker techniques for atrial fibrillation because they offer a fresh approach to managing heart rhythm issues. Unlike standard treatments that rely heavily on medications for rate control, the P&A-CSP technique involves a combination of conduction system pacing (CSP) and catheter atrioventricular node ablation (AVNA), potentially providing more precise heart rate management. Additionally, integrating an implantable cardioverter-defibrillator (ICD) for patients with reduced heart function (LVEF ≤35%) could enhance safety and outcomes. This method could offer faster and more targeted relief for patients, reducing their reliance on medications and potentially improving quality of life.

What evidence suggests that this trial's pacemaker techniques could be effective for atrial fibrillation?

This trial will compare two approaches for managing atrial fibrillation (AF): pharmacological therapy and the "pace-and-ablate" strategy. Studies have shown that using a pacemaker with AV node ablation, which participants in the "pace-and-ablate" arm may receive, effectively manages AF, especially when symptoms are severe and other treatments are ineffective. Research indicates that this approach can improve heart function and reduce symptoms like irregular heartbeats. A review highlights the growing popularity of this technique, as it allows the pacemaker to fully control the heart's rhythm, leading to better outcomes. Additionally, a meta-analysis found that the "pace-and-ablate" strategy can result in fewer complications compared to other treatments like medication or AF ablation. This method is particularly beneficial for those who cannot tolerate traditional medications. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Pace and Ablate

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Published Research Related to This Trial

In a study of 170 patients with drug-refractory atrial fibrillation, catheter ablation of the atrioventricular junction (AVJ) was highly successful, achieving complete AV block in 97.6% of cases, with a mean follow-up of 26 months showing persistence of this block in 96% of patients.

The procedure was performed safely with a mean ablation time of just 7 minutes and low fluoroscopy exposure (3.1 minutes), indicating that the superior vena cava approach may be advantageous compared to traditional methods.

NCBI (Pubmed)

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. Issa, ZF., Amr, BS., Laham, H.[2015]

Conduction system pacing has made 'ablate and pace' procedures for atrial fibrillation more accessible, allowing for a simpler and more physiological way to pace the ventricles.

The article discusses the technical aspects, current evidence, and future directions of this pacing strategy, highlighting its growing acceptance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of conduction system pacing in ablate and pace strategies for atrial fibrillation. Tung, R., Burri, H.[2023]

In a study of 127 patients undergoing AVN ablation, leadless pacemakers (LPs) showed comparable efficacy to single-chamber conventional transvenous pacemakers (CTPs), with 95% of LP patients meeting the primary efficacy endpoint for sensing and pacing thresholds.

The safety profile of LPs was similar to that of CTPs, with only one major adverse event in the LP group compared to two in the CTP group, indicating that LPs are a feasible and safe alternative for patients with atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation. Yarlagadda, B., Turagam, MK., Dar, T., et al.[2019]

In a study of 96 patients who underwent AV node ablation and pacemaker implantation, 79% had an escape rhythm immediately after the procedure, but 28% experienced variability in their escape rhythm over time, indicating potential pacemaker dependency.

Overall, 72% of patients maintained a stable escape rhythm, but the presence of a labile escape rhythm suggests some patients may be at risk for complications related to pacemaker failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just how stable are escape rhythms after atrioventricular junction ablation? Arora, R., Spatz, E., Vijayaraman, P., et al.[2010]

A meta-analysis of 93 studies involving 11,340 patients showed that atrioventricular node ablation (AVNA) combined with pacemaker implantation has a low 30-day mortality rate of 1.08%, but long-term evidence on its effectiveness is limited.

Younger patients with lower left ventricular ejection fraction (LVEF) experienced higher rates of cardiac mortality after AVNA with right ventricular pacemakers, suggesting that alternative treatments may be necessary for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrioventricular node ablation and pacing for atrial tachyarrhythmias: A meta-analysis of postoperative outcomes. Baudo, M., D'Ancona, G., Trinca, F., et al.[2022]

In a study of 56 atrial fibrillation patients with heart failure, left bundle branch area pacing (LBBaP) combined with atrioventricular node ablation (AVNA) was found to be safe and effective, leading to significant improvements in cardiac function over 1 year.

Key predictors of improvement in left ventricular ejection fraction after LBBaP included baseline measurements such as left ventricular ejection fraction and QRS duration, while factors like right atrial diameter and tricuspid regurgitation influenced the success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Left Bundle Branch Area Pacing Combined with Atrioventricular Node Ablation in Atrial Fibrillation Patients with Heart Failure. Jin, QQ., Zheng, C., Wang, YJ., et al.[2022]

Direct His bundle pacing, as demonstrated in a case study, offers a promising alternative to traditional right ventricular pacing for patients undergoing atrioventricular nodal ablation, potentially reducing long-term adverse effects.

Biventricular pacing has been shown to significantly improve functional capacity compared to right ventricular pacing, highlighting the importance of exploring different pacing sites for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct His bundle pacing post AVN ablation. Lakshmanadoss, U., Aggarwal, A., Huang, DT., et al.[2009]

In a study of 163 elderly patients (average age 71) with atrial fibrillation, radiofrequency ablation of the AV node followed by pacemaker implantation was found to be an effective and safe treatment, with 42% of patients becoming pacemaker-dependent after a mean follow-up of 36 months.

While 42% of patients were classified as pacemaker-dependent and experienced symptoms like dizziness and syncope, there were no significant differences in serious clinical outcomes such as stroke or heart failure hospitalizations between pacemaker-dependent and non-dependent patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pacemaker dependence in patients on ablate and pace therapy for atrial fibrillation. Occhetta, E., Bortnik, M., Dell'era, G., et al.[2010]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10380427/

Outcomes of Atrioventricular Node Ablation and Pacing in ...

Conclusions: Atrioventricular node ablation and pacemaker implantation is shown to have beneficial effects on clinical outcomes of patients with atrial ...

2.

revportcardiol.org

revportcardiol.org/en-pace-ablate-the-ultimate-treatment-articulo-S217420492100043X

Pace and ablate: The ultimate treatment for atrial fibrillation?

Pacemaker treatment combined with atrioventricular (AV) node ablation is an effective treatment in patients with atrial arrhythmias and symptoms due to high ...

3.

academic.oup.com

academic.oup.com/eurheartj/article/45/46/4887/7821007

Atrioventricular node ablation for atrial fibrillation in the era of ...

This review will discuss the role of permanent pacemaker implantation and AVNA for AF management in this new era of conduction system pacing.

4.

ahajournals.org

ahajournals.org/doi/10.1161/01.cir.101.10.1138

Clinical Outcomes After Ablation and Pacing Therapy for ...

Ablation and pacing therapy improves a broad range of clinical outcomes for patients with medically refractory atrial fibrillation.

5.

acc.org

acc.org/latest-in-cardiology/ten-points-to-remember/2024/12/17/04/37/atrioventricular-node-ablation

AV Node Ablation for AF in Conduction System Pacing

A recent network meta-analysis found that a pace-and-ablate approach, compared with AF ablation or pharmacotherapy, had the lowest rates of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10682904/

Conduction system pacing and atrioventricular node ablation ...

This is the first randomized trial specifically addressing the long‐term efficacy and safety of this pace‐and‐ablate strategy in patients with HFpEF/HFmrEF and ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06152406

Study Details | NCT06152406 | Ablate and Pace HIS Study

Following AV node ablation, it is understandable that these patients will be paced 100% of the time where the value of physiological pacing will be at its most.