Dr Moussa Mansour (Massachusetts General Hospital, Boston, MA, US) shares updates from the PRECEPT Study.
The objective of the Persistent atrial fibrillation ablation with contact force sensing catheter: The prospective multicenter PRECEPT Trial is to evaluate the safety and effectiveness of catheter ablation of PsAF using a porous tip contact force (CF)-sensing catheter.
1. What are the current challenges with treating persistent AF?
2. Why was PRECEPT conducted?
3. What was the study design?
4. What were the results?
5. What conclusions can be made as a result of this study?
HRS 2020, recorded remotely from Boston.
Interviewer: Mirjam Boros
Recording Specialist: Natascha Wienand
Transcript Below :
Question 1 : What are the current challenges with treating persistent AF?
The data with ablation of paroxysmal atrial fibrillation, is, there is large number of data. However, the data is lacking for persistent atrial fibrillation. So, knowing the optimal procedure for persistent atrial fibrillation, knowing the outcome of persistent atrial fibrillation in a large multi-centered study is relatively unknown.
Question 2 : Why was PRECEPT conducted?
The PRECEPT study is the first multi-national, multi-center FDA sponsored study for persistent atrial fibrillation. We have significant data on the treatment of paroxysmal atrial fibrillation, but the data for persistent atrial fibrillation is lacking. So the aim from PRECEPT study is to demonstrate the efficacy and safety of catheter ablation for persistent atrial fibrillation in a multi-center prospective design.
Question 3 : What was the study design?
The PRECEPT is the first multi-center study for persistent atrial fibrillation under FDA sponsorship. Many studies were done for paroxysmal atrial fibrillation but none has been done with persistent atrial fibrillation. 26 centers were enrolled in the United States and Canada. 300, in excess of 380 patients. It has a prospective design. Follow-up was 15 month which is extensive and also the patient had a very meticulous follow-up including frequent ambulatory monitors and testing. The follow up is also unique and it is geared toward a persistent population of study. And the design of the study was later incorporated into the atrial fibrillation ablation consensus guidelines, and I will elaborate on that a little bit. So the study had 15 month follow-up. Most of the studies of A Fib ablation had only a 12 month follow-up. And the reason for the 15 month follow-up is because we had in PRECEPT six months blanking period instead of three. And I will tell you what the reasons are. In most patients with persistent atrial fibrillation, after ablations, some of the investigators or operators may use some medications in the first three months. We did not want the effect of the medications to be carried over and dilute the effect of ablation. As a result, we extended the blanking period to six months so they will have no more effect of the medication that some of them could have been used in the first three months. And because of that we extended the follow-up to a total of 15 month which I believe is very adequate.
Question 4 : What were the results?
The study had two end points, a primary safety endpoint and the primary effectiveness endpoint. And both endpoints were met. For the primary safety endpoint, the complication, the adverse event rate was very small and it beat the expected number of safety events. The primary effectiveness endpoint which is a very strict endpoint, consisting of freedom from atrial fibrillation of no more than 30 seconds, was achieved in 61.7% of the patients. In addition to the primary effectiveness endpoint, we also had a clinical success endpoint which may be more relevant for patients with persistent atrial fibrillation where the 30 second rule may not apply well. And this study, in PRECEPT study, this clinical success endpoint was reached in 80% of the patients. Many of us don’t believe that the 30 second recurrence rate of atrial fibrillation may be relevant for patients with persistent A Fib. But we also know that this is the standard that needs to be followed by most societies and by most clinical trial regulatory foundations or institutions. So, we had to show that but also we showed we showed a clinical success endpoint. In addition to the primary safety and primary effectiveness endpoint we also looked at the quality of life, we looked at the rate of re-do ablation and we looked at healthcare utilisation and we found that ablation of persistent atrial fibrillation improved all those end oints.
Question 5 : What conclusions can be made as a result of this study?
We learned a lot from the PRECEPT study. It is a first prospective study, multi-center for persistent atrial fibrillation ablation. It showed that ablation, when performed with a contact-force catheter, is associated with a low complication rate and provides a high level of effectiveness. We also showed that ablation improves the quality of life of the patients, reduces healthcare utilisation and is associated with a low rate of recurrence.