Periodic Reporting for period 1 - BEAT AF (Ground-BrEAking Electroporation-based inTervention for Atrial Fibrillation treatment (BEAT AF))
Okres sprawozdawczy: 2021-03-01 do 2022-08-31
Atrial fibrillation (AF), the most common arrhythmia, accounts for 1/3rd of cardiovascular expenses, with over 10 million affected in Europe. In addition to significant impact on quality of life, AF exposes patients to stroke, heart failure, dementia and death. This arrhythmia is characterized by abnormalities in electrical impulse formation and conduction within the heart.
Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing arrhythmia recurrences. Catheter ablation of AF uses either radio frequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is the fact that these modalities ablate all tissue types indiscriminately, exposing patients to some complications. The ablation procedure remains long, requires skills and expertise, and has a limited success rate, mostly because of non-durable lesions after PVI implying frequent redo procedures. These energies are associated with rare but severe complications due to their thermal nature. It remains suboptimal with safety and efficacy issues, and can only be delivered by highly trained specialists. Complications and duration of the procedure itself directly affect the time spent in the operating theatre and hospital as well as associated costs.
The goal of BEAT AF is to disrupt AF ablation by achieving durable PVI with permanent, coalescent and transmural ablation lesions using Pulsed Electric Field (PEF) energy. PEF is non-thermal and creates nanoscale pores in cell membranes. This energy has some tissue selectivity: cardiac cells are highly sensitive to PEF unlike phrenic and esophageal cells. BEAT AF aims to demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF or cryo ablation. For this purpose, two distinct randomized clinical trials will be conducted: 1) to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal AF, and 2) to provide first evidence of potential efficacy of PEF on the rate of 1-year clinical recurrence for persistent AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to set the ground for large trials and contribute to decrease the huge burden of AF in Europe.
Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing arrhythmia recurrences. Catheter ablation of AF uses either radio frequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is the fact that these modalities ablate all tissue types indiscriminately, exposing patients to some complications. The ablation procedure remains long, requires skills and expertise, and has a limited success rate, mostly because of non-durable lesions after PVI implying frequent redo procedures. These energies are associated with rare but severe complications due to their thermal nature. It remains suboptimal with safety and efficacy issues, and can only be delivered by highly trained specialists. Complications and duration of the procedure itself directly affect the time spent in the operating theatre and hospital as well as associated costs.
The goal of BEAT AF is to disrupt AF ablation by achieving durable PVI with permanent, coalescent and transmural ablation lesions using Pulsed Electric Field (PEF) energy. PEF is non-thermal and creates nanoscale pores in cell membranes. This energy has some tissue selectivity: cardiac cells are highly sensitive to PEF unlike phrenic and esophageal cells. BEAT AF aims to demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF or cryo ablation. For this purpose, two distinct randomized clinical trials will be conducted: 1) to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal AF, and 2) to provide first evidence of potential efficacy of PEF on the rate of 1-year clinical recurrence for persistent AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to set the ground for large trials and contribute to decrease the huge burden of AF in Europe.
The BEAT AF consortium had the opportunity to meet in Bordeaux (FR) for the first time in September 2022, following pandemic travel regulation. This first face to face event allowed the team to review the work they carried out together over the past 18 months. During this time, priority was given to overviewing the trial’s next steps as patients started joining BEAT AF as of December 2021.
The steering committee meeting saw important decisions made in preparing the project to pick up speed on inclusions. Notably, clinical centers presented provisional inclusions rates based on current activity. These rates repair the delay incurred by complex regulatory aspects linked to the challenge of multi-site trials. Along with this decision, all centers accepted to take part in the “Redo” sub study, a procedure that is already part of routine care, boosting the power of this particular sub study.
Every essential aspect of BEAT AF is identified as a specific set of actions carried out by team members who are experts in their own fields. These taskforces cover clinical trial management, investigational devices, data collection and analysis, safety and ethics. A management team offers strong framework aided by a communication team. Their objectives are to build strong relations with stakeholders and focus effort on the dissemination of results across the widest possible range of audiences.
Active investigators had the opportunity to expose their progress to the public and the consortium. They reported the good news that in spite of the challenge that European clinical trial regulation presents, patient recruitment rates for clinical centers across Europe were promising, even if COVID’s resurgence is impacting the trial. As more patients join, the project’s activity generates data essential for research. This data is collected from all 9 clinical centers across Europe in order to analyse the outcome of the treatment. The challenge presented by this action is to create a centralized database designed to store and exchange “raw” and analysed data from each center. To prepare for the clinical trials, the data management team ran a series of tests – collecting data from each center in order to anticipate transfer issues linked to software and data formats. They reported on the successful collection of this data and on the technical support they have been providing to the consortium.
This event marked the end of an important first chapter for BEAT AF. Reviewing concrete results together was an essential effort towards better collaboration for research excellency in the field of Atrial Fibrillation treatment. The great relations nurtured among the consortium will ultimately facilitate research for consistent results that promise great progress for AF patients everywhere. Finally, the decision to publish the trial’s methodology was made.
The steering committee meeting saw important decisions made in preparing the project to pick up speed on inclusions. Notably, clinical centers presented provisional inclusions rates based on current activity. These rates repair the delay incurred by complex regulatory aspects linked to the challenge of multi-site trials. Along with this decision, all centers accepted to take part in the “Redo” sub study, a procedure that is already part of routine care, boosting the power of this particular sub study.
Every essential aspect of BEAT AF is identified as a specific set of actions carried out by team members who are experts in their own fields. These taskforces cover clinical trial management, investigational devices, data collection and analysis, safety and ethics. A management team offers strong framework aided by a communication team. Their objectives are to build strong relations with stakeholders and focus effort on the dissemination of results across the widest possible range of audiences.
Active investigators had the opportunity to expose their progress to the public and the consortium. They reported the good news that in spite of the challenge that European clinical trial regulation presents, patient recruitment rates for clinical centers across Europe were promising, even if COVID’s resurgence is impacting the trial. As more patients join, the project’s activity generates data essential for research. This data is collected from all 9 clinical centers across Europe in order to analyse the outcome of the treatment. The challenge presented by this action is to create a centralized database designed to store and exchange “raw” and analysed data from each center. To prepare for the clinical trials, the data management team ran a series of tests – collecting data from each center in order to anticipate transfer issues linked to software and data formats. They reported on the successful collection of this data and on the technical support they have been providing to the consortium.
This event marked the end of an important first chapter for BEAT AF. Reviewing concrete results together was an essential effort towards better collaboration for research excellency in the field of Atrial Fibrillation treatment. The great relations nurtured among the consortium will ultimately facilitate research for consistent results that promise great progress for AF patients everywhere. Finally, the decision to publish the trial’s methodology was made.
BEAT AF addresses a widespread non-communicable, chronic medical condition that not only constitutes a significant burden on the health and quality of life for the concerned patients, but also poses significant pressure on healthcare system through:
a) long-term pharmacological treatment of AF, treatment of resulting co-morbidities and management of complications (e.g. hospitalizations, emergency care), and
b) costs and complexity of catheter ablation treatment.
By replacing routine thermal PVI with superior, safer and way easier to use PEF energy for cardiac ablation, BEAT AF implements an innovative and effective healthcare intervention providing superior care to more AF patients. Over the last 30 years, no new technology has reached this level of hope in the field. The BEAT AF partners are very excited to participate in a landmark effort!
BEAT AF trials aim at reporting improved hard outcomes, offering an ultra-rapid durable PVI with excellent durable safety to patients. We do believe that among other major clinical benefits, it will completely change patients’ experience and facilitate their decision process to undergo ablation, allowing for earlier ablation procedures.
BEAT AF will pave the way for widespread acceptance of the new technology and drive establishment of PEF ablation for AF in clinical practice within 3 to 4 years. Outcomes for patients and disease burden, both in terms of population access to PEF ablation for AF as well as disease progression and quality-of-life for the individual patient will be greatly improved.
One of BEAT AF’s goals is to establish PEF ablation for AF in medical guidelines for the treatment of these patients. To do so we will provide evidence-based medicine through our two clinical studies and preliminary findings on potential reduction in healthcare costs (e.g. all-cause rehospitalizations, cardiovascular rehospitalizations for AF related and non–AF related, redo procedures, time spent under anti-arrhythmic drugs). Ultimately, this will provide a safer, and more (cost-) effective way of treating patients with atrial fibrillation.
a) long-term pharmacological treatment of AF, treatment of resulting co-morbidities and management of complications (e.g. hospitalizations, emergency care), and
b) costs and complexity of catheter ablation treatment.
By replacing routine thermal PVI with superior, safer and way easier to use PEF energy for cardiac ablation, BEAT AF implements an innovative and effective healthcare intervention providing superior care to more AF patients. Over the last 30 years, no new technology has reached this level of hope in the field. The BEAT AF partners are very excited to participate in a landmark effort!
BEAT AF trials aim at reporting improved hard outcomes, offering an ultra-rapid durable PVI with excellent durable safety to patients. We do believe that among other major clinical benefits, it will completely change patients’ experience and facilitate their decision process to undergo ablation, allowing for earlier ablation procedures.
BEAT AF will pave the way for widespread acceptance of the new technology and drive establishment of PEF ablation for AF in clinical practice within 3 to 4 years. Outcomes for patients and disease burden, both in terms of population access to PEF ablation for AF as well as disease progression and quality-of-life for the individual patient will be greatly improved.
One of BEAT AF’s goals is to establish PEF ablation for AF in medical guidelines for the treatment of these patients. To do so we will provide evidence-based medicine through our two clinical studies and preliminary findings on potential reduction in healthcare costs (e.g. all-cause rehospitalizations, cardiovascular rehospitalizations for AF related and non–AF related, redo procedures, time spent under anti-arrhythmic drugs). Ultimately, this will provide a safer, and more (cost-) effective way of treating patients with atrial fibrillation.