RecruitingNAINTERVENTIONAL

Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)

This study, called 'Conquer-AF', is for individuals in the UK, USA, and Australia who experience a treatable heart condition called atrial fibrillation (AF). AF causes an irregular and often fast heartbeat. This study specifically targets people whose AF has returned after having a previous treatment called ablation. The aim is to test a new system, including a device called the Sphere-9 Catheter, to see if it's a safe and effective way to treat these recurring AF episodes. Participants will have this new procedure and then be monitored for 12 months to see how well it works and if their AF stays under control. The entire study is expected to last about two years.

At a glance

Status

Recruiting

Phase

Sponsor

Medtronic Cardiac Ablation Solutions

Enrolment target

400

Start

08 Apr 2026

Estimated completion

29 Mar 2028

Atrial Fibrillation (AF)Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation (PAF)

What is this study about?

You might be reading this because you or someone you know has atrial fibrillation (AF), which is a common condition where the heart beats irregularly. While there are treatments for AF, sometimes it can come back even after having a procedure to fix it.

This study is called 'Conquer-AF' and it's designed to help people whose AF has returned after having one previous treatment called 'ablation'. Ablation is a procedure where doctors use heat or cold to create tiny scars in the heart tissue that send out irregular electrical signals, stopping them from causing AF. The study aims to test a new way of performing this ablation procedure, using a special device called the Sphere-9 Catheter and a related system. The main goal is to see if this new approach is a safe and effective way to treat recurring AF.

Researchers want to find out if this new method can help keep AF away for longer and improve the quality of life for people who have had their AF come back. The study will carefully follow participants to collect information about how well the new treatment works and if there are any side effects. This research is important because it could lead to better treatment options for people with recurring AF.

Key takeaways

Tests a new ablation device for recurring AF.
For individuals whose AF has returned after one previous ablation.
Involves a repeat ablation procedure and 12 months of follow-up.
Aims to find a more effective way to treat recurring AF.
Participation includes regular check-ups to monitor your heart.

Who may be eligible?

To be part of this study, you would need to meet certain requirements. Firstly, you must have been diagnosed with atrial fibrillation (AF) that has caused symptoms and has returned after you've already had one ablation procedure. This previous ablation procedure must have taken place within the last three years. You also need to be 18 years or older.

There are also some reasons why you might not be able to join. For example, if your AF has been continuous for a year or longer, or if you've already had more than one ablation procedure. Certain heart conditions, or if you're not able to take specific blood-thinning medication (anticoagulants), might also mean you can't participate. The doctors will review all these details carefully to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Has your heart condition (AF) caused symptoms that have come back?
Have you had one previous ablation procedure for AF within the last 3 years?
Are you 18 years old or older?
Are you able to take blood-thinning medication as prescribed?
Have you *not* had AF continuously for 12 months or longer?
Have you *not* had more than one previous AF ablation?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll undergo a repeat ablation procedure using the new Sphere-9 Catheter and Affera Ablation System. This procedure is similar to a standard ablation but uses the new technology being tested. After the procedure, you'll have several follow-up appointments over 12 months. These appointments will typically be at 7 days, 3 months, 6 months, and 12 months after your procedure. At each visit, doctors will check how you're feeling and monitor your heart rhythm, including a 24-hour heart monitor (Holter) at the final 12-month visit. The entire study journey, from your first visit to your last follow-up, is expected to take about 13 months for each participant.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach for recurring atrial fibrillation before it's widely available. The aim is to see if this new method can be more effective in managing your AF symptoms. However, like all medical procedures, the ablation carries potential risks, including bleeding, infection, and damage to heart tissue. The research team will explain all known risks in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

University of Alabama at Birmingham (UAB) Hospital
Verified postcode
Birmingham, United States· Not yet recruiting
Scripps Green Hospital
Verified postcode
La Jolla, United States· Not yet recruiting
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States· Not yet recruiting
NCH Rooney Heart Institute
Verified postcode
Naples, United States· Recruiting
AdventHealth Cardiovascular Research Institute
Verified postcode
Orlando, United States· Not yet recruiting
Piedmont Heart Institute
Verified postcode
Atlanta, United States· Not yet recruiting
Memorial Health University Medical Center
Verified postcode
Savannah, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Verified postcode
Kansas City, United States· Not yet recruiting
Northwell Health Lenox Hill Hospital
Verified postcode
New Hyde Park, United States· Not yet recruiting
NYU Langone Medical Center
Verified postcode
New York, United States· Not yet recruiting
Montefiore Medical Center
Verified postcode
The Bronx, United States· Not yet recruiting

Common questions

What is 'atrial fibrillation'?

Atrial fibrillation is a common heart condition where your heart beats irregularly and often very fast. This can make you feel tired, dizzy, or breathless.

What is 'ablation'?

Ablation is a procedure that uses heat or cold to create tiny scars in your heart. These scars block the faulty electrical signals that cause your heart to beat irregularly.

Why is this study only for people who've had a previous ablation?

This study is specifically looking at a new device for people whose atrial fibrillation has returned after they've already had one ablation procedure, to see if it can be a better option in these cases.

How long will I be in the study?

If you participate, you will have the procedure and then be followed for 12 months after, with several check-up appointments during that time.

Will I have to pay to be in the study?

Clinical trials usually cover the costs of the study treatment and appointments. This will be fully explained when you consider joining the study.

How to find out more

Ryan S Radtke, Bachelors of Science- Biology

ryan.s.radtke@medtronic.com 712-941-9372 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.