Active not recruitingNAINTERVENTIONAL

CONVERGE Post-Approval Study (PAS)

This study, called CONVERGE Post-Approval Study (PAS), is checking how well a new treatment works for a specific type of irregular heartbeat called "long-standing persistent atrial fibrillation." This is when your heart beats irregularly for a long time and hasn't responded to usual medications. The treatment uses a special device called EPi-Sense and involves a combined approach that targets both the outside and inside of the heart. The main goal is to see how patients do after this treatment, looking at both short-term recovery and long-term results. The study aims to confirm previous findings and ensure the treatment is effective and safe for a wider range of patients and doctors.

At a glance

Status

Active not recruiting

Phase

Sponsor

AtriCure, Inc.

Enrolment target

Start

13 Apr 2022

Estimated completion

21 Nov 2028

Chronic Atrial Fibrillation

What is this study about?

This study, called CONVERGE PAS, is looking at a new treatment for a heart condition called "long-standing persistent atrial fibrillation" (AF). This is a type of irregular heartbeat that has been present for a long time and hasn't gotten better with standard medicines. Having this condition can increase your risk of stroke.

Currently, there aren't many approved treatment options for people with this specific type of AF. The CONVERGE PAS study is designed to gather more information on a treatment that uses a special device and combines two ways of treating the heart: one from the outside and one from the inside. This approach has already been used successfully in many patients over the past decade. The study wants to make sure this treatment is safe and effective in a wider group of patients and with different doctors performing the procedure.

The main aim is to confirm that the EPi-Sense device and the combined treatment approach are working well. It also wants to show that new guidelines for patient care can help reduce any potential risks and that the treatment works consistently, no matter how much experience the doctor has. Finally, it will collect information on how patients are doing a long time after their procedure.

Key takeaways

This study evaluates a treatment for a long-term, stubborn irregular heartbeat.
It uses a device called EPi-Sense and a combined heart procedure.
The goal is to confirm the treatment's safety and effectiveness over time.
It aims to improve care guidelines and ensure the treatment works for many patients.
Participation involves undergoing the procedure and follow-up monitoring.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old. You must have long-standing persistent atrial fibrillation that causes symptoms like feeling your heart race, shortness of breath, or tiredness, and it needs to be a type that hasn't responded well to at least one heart rhythm medicine. Your heart's left upper chamber (atrium) shouldn't be too large, and you must be expected to live for at least another year.

There are several reasons why someone might not be able to join. For example, if you need other heart surgeries at the same time, or if you have severe heart pumping problems, a history of certain heart or brain conditions, or active infections. People who are pregnant or planning to be, can't take blood thinning medications, or have certain stomach or kidney problems would also not be able to participate. If you've had too many previous procedures to treat your AF, you also wouldn't be eligible.

Quick self-check

Are you between 18 and 80 years old?
Do you have a long-term, symptomatic irregular heartbeat (AF) that hasn't responded to medication?
Is your heart's main upper chamber (left atrium) not too enlarged?
Are you able to take blood-thinning medications if needed?
Have you not had more than two previous, unsuccessful heart ablation procedures for AF?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study is gathering information during the commercial use of the EPi-Sense system after it has already been approved. Taking part would involve undergoing the Hybrid Convergent procedure, which uses the EPi-Sense device. After the procedure, you would have follow-up visits and assessments to monitor your health and the success of the treatment. The study will track your progress over a long period to understand the lasting effects of the procedure. Specific details about the number of visits, tests, and the total duration would be explained by the study team, but generally, it involves ongoing monitoring after your treatment.

Potential risks and benefits

The potential benefits of joining this study include receiving a treatment that has shown promise for long-standing persistent atrial fibrillation, a condition that currently has limited approved options. This treatment could help manage your irregular heartbeat and improve your symptoms. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or other complications related to heart procedures. The study aims to further understand and reduce these risks. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (13)

Sutter Bay Hospitals
San Francisco, United States
Hartford Hospital
Hartford, United States
Baycare Health Systems
Clearwater, United States
Orlando Health
Orlando, United States
Emory Saint Joseph Hopsital
Atlanta, United States
Wellstar Health System
Marietta, United States
Norton Heart & Vascular Institute
Louisville, United States
MedStar Union Memorial Hospital
Baltimore, United States
Southcoast Hospitals Group
New Bedford, United States
AtlantiCare Medical Center
Atlantic City, United States
Avera Heart Hospital of SD
Sioux Falls, United States
University of Utah
Salt Lake City, United States

+1 more sites — see the official record for the full list.

Common questions

What is long-standing persistent atrial fibrillation?

It's a type of irregular heartbeat that has been present for more than 12 months and doesn't get better with usual medications.

What is the EPi-Sense device?

It's a special tool used in a procedure to treat irregular heartbeats by targeting specific areas of the heart.

Why is this study important?

It helps us learn more about how well this new treatment works for a challenging heart condition that needs more effective options.

Will I have to pay to be in the study?

Most clinical trials cover the costs of the experimental treatment and study-related visits, but you should always confirm this with the study team.

Can I leave the study once I've started?

Yes, you can choose to leave the study at any time, and this will not affect your regular medical care.