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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
Are there results?
None posted in the registry

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
Show all 9Show fewer
  • 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

Other trials in France

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.

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 groups in NCT04229160
Study groupRoleWhat they receive
patient with persistent atrial fibrillationExperimentalpersistent 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.

  1. Number of focal sources and rotors in atrial segments

    Measured: within 1 hour post-cardioversion procedure

  2. Number of focal sources and rotors in atrial segments

    Measured: within 1 hour post-Pulmonary Vein Isolation procedure

Secondary outcomes (2)

  1. Number of Atrial Fibrillation recurrence following AF ablation procedure

    Measured: 1 year post-procedure

  2. 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.

  1. First posted18 Jan 2020
  2. Study start9 Jun 2020
  3. Primary completion17 Jun 2026
  4. Study completion17 Jun 2026

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of focal sources and rotors in atrial segments (time frame: within 1 hour post-cardioversion procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04229160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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