Atrial Fibrillation, PersistentCRYOVESTNCT04229160
Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success
A study testing Noninvasive mapping (Cardioinsight® system), long-term cardiac monitoring (LINQ system) and Atrial Fibrillation ablation procedure in people with Atrial Fibrillation, Persistent, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Noninvasive mapping (Cardioinsight® system), long-term cardiac monitoring (LINQ system) and Atrial Fibrillation ablation procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesFrance
- Study dates
- 9 Jun 2020to 17 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented persistent Atrial Fibrillation lasting longer than 6 months documented by 24h holter monitoring
- Age between 18 and 75 years
- Efficient oral anticoagulation during at least 1 month before the procedure
- Social security affiliation
- Feasible patient follow-up
- Patient willing to comply with study requirements and give informed consent to participate in this clinical study
- Indication for Pulmonary Vein isolation
Who cannot join
- Previous atrial fibrillation ablation
- Previous left atrial ablation or surgery
- Atrial fibrillation without spontaneous RR interval > 1000ms and with LVEF < 35% (measured by TTE)
- Presence of a mechanical mitral valve
- Current intracardiac thrombus
- Any condition contraindicating chronic anticoagulation
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- Uncontrolled hyperthyroidism
- Anteroposterior LA diameter > 55 mm measured by TTE
- Body mass index ≥ 40 kg/m2
Trial locations and contacts
4 sites in 1 country.
France4 sites
Caen University Hospital
Caen
Dieppe Hospital
Dieppe
Groupe Hospitalier du Havre
Le Havre
Rouen University Hospital
Rouen
About this study
Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. AF ablation is a class IIa treatment for patients with symptomatic persistent AF refractory or intolerant to antiarrhythmic medication. There are still many debates considering the ablation strategy. The pulmonary veins remain the cornerstone of AF ablation therapy, even in persistent AF. There is a large electrical remodeling occurring in the left atrium between paroxysmal AF, early persistent AF and long-standing persistent AF. However, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources.
Our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent AF > 6 months pre- and post-cardioversion, and after pulmonary vein isolation.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Noninvasive mapping (Cardioinsight® system), long-term cardiac monitoring (LINQ system), Atrial Fibrillation ablation procedure
- Keywords
- pulmonary vein isolation, cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive mapping (Cardioinsight® system)Device
Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure
long-term cardiac monitoring (LINQ system)Device
long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure
Atrial Fibrillation ablation procedureProcedure or surgery
Atrial Fibrillation ablation procedure is done with standard practice
| Study group | Role | What they receive |
|---|---|---|
| patient with persistent atrial fibrillation | Experimental | persistent atrial fibrillation is defined as lasting longer than 6 months documented by a 24h holter monitoring Receives: Device: Noninvasive mapping (Cardioinsight® system); Device: long-term cardiac monitoring (LINQ system); Procedure: Atrial Fibrillation ablation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of focal sources and rotors in atrial segments
Measured: within 1 hour post-cardioversion procedure
Number of focal sources and rotors in atrial segments
Measured: within 1 hour post-Pulmonary Vein Isolation procedure
Secondary outcomes (2)
Number of Atrial Fibrillation recurrence following AF ablation procedure
Measured: 1 year post-procedure
Number of success of Atrial Fibrillation induction after initial electrical cardioversion
Measured: within 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start9 Jun 2020
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ANSELME, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229160
- Sponsor's protocol ID
- 2018/0418/HP
- Acronym
- CRYOVEST
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No