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Atrial FlutterPAF CRIOBLAFNCT01521988

Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation

A study testing Atrial flutter ablation and Atrial flutter ablation and pulmonary vein isolation in people with Atrial Flutter and Atrial Fibrillation, run by University Hospital, Rouen at 15 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

Background: Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation that occurs in about 70% of these… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atrial Flutter, Atrial Fibrillation
What is being tested?
Atrial flutter ablation and Atrial flutter ablation and pulmonary vein isolation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
15 sitesFrance
Study dates
Jun 2012to Apr 2018
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

  • Patient with a spontaneous flutter or with a flutter recurrence when it was not considered appropriate to use a preventive treatment so far. The flutter may have been paroxysmal or may still be present.
  • Patient with at least one documented episode of typical flutter defined as follows: negative F waves in the inferior territory, positive in V1 and negative in V6 lead, F wave pattern with characteristic "saw tooth" appearance and finally a heart rate comprised between 240 and 320 beats per minute.
  • Patient with effective anticoagulant therapy for at least 3 weeks.
  • Patient with at least one episode of AF (lasting more than 1 minute) documented on an ECG or a 24 hour Holter recording
  • Patient who signed an informed consent.
  • Patient with age ≥ 18 yo and ≤ 75 yo

Who cannot join

  • Patients with the following characteristics will be excluded:
  • Contraindication to right-heart catheterization
  • Contraindication to an anticoagulant treatment
  • Patient for which AF is predominant (more recordings of AF than Flutter)
  • Persistent AF at the time of inclusion visit
  • History of mitral valve surgery
Show all 13Show fewer
  • Known disorders of blood clotting
  • Cardiothyreosis
  • Life expectancy < 24 months
  • Less than 18 years old and pregnant ladies. As before any ablation, a pregnancy test will be done the day before or the day of the procedure
  • Patient less than 18 years old
  • Patient under guardianship
  • Patient deprived of their liberty by a court decision

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CHU de Brest

    Brest

  • CHU Grenoble

    Grenoble, 38000

  • CH La Rochelle

    La Rochelle

  • AP-HM - Hôpital Nord

    Marseille

  • Hôpital Privé de Clairval

    Marseille

  • CHU de Nantes

    Nantes

  • Nouvelles Cliniques Nantaises

    Nantes

  • CHU de Rennes

    Rennes, 35033

  • University Hospital of Rouen

    Rouen, 76000

  • CHU de Strasbourg

    Strasbourg

  • Clinique Pasteur

    Toulouse, 31076

  • CHU de Tours

    Tours

  • Clinique Saint Gatien

    Tours

  • Clinique Saint Joseph

    Trélazé

  • Polyclinique Vauban

    Valenciennes

Other trials in France

About this study

Official title: Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter

  • Background:

Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation that occurs in about 70% of these patients after several years of follow-up. However, the latter arrhythmia is associated with significant morbidity and mortality. The problem of atrial fibrillation occurrence after successful ablation of typical atrial flutter remains physicians primary concern in monitoring these patients.

Read more
  • Objectives:

The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon cryotherapy technology performed at the time of flutter ablation, significantly reduces the risk of developing atrial fibrillation in the two year period following the procedure.

  • Selection Criteria:

Patients referred for ablation of typical atrial flutter with an history of at least one documented episode of atrial fibrillation (atrial flutter remaining the predominant arrhythmia)will be enrolled in the study.

  • Study Methods:

This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial fibrillation occurrence over a two years period following either an ablation procedure of typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18 months.

Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then be regularly followed up clinically and by long-term ECG recordings.

  • Evaluation Criteria:

The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation, documented by an ECG or an R-test, occurring between M3 and M24

  • Number of patients: 170 patients will be enrolled in the study
  • Number of centers:

Four French and three German centers will participate.

  • Perspective:

The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the patient group with pulmonary vein isolation, could lead to a modification of atrial arrhythmia treatment indication.

Being tested
Atrial flutter ablation, Atrial flutter ablation and pulmonary vein isolation
Keywords
Atrial flutter, Atrial fibrillation, Catheter ablation
Medical subject headings
Atrial Flutter, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atrial flutter ablationProcedure or surgery

    Radiofrequency ablation of Atrial flutter

  • Atrial flutter ablation and pulmonary vein isolationProcedure or surgery

    Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation

Study groups in NCT01521988
Study groupRoleWhat they receive
Atrial flutter ablationActive comparatorRF atrial flutter ablation
Receives: Procedure: Atrial flutter ablation
Atrial flutter ablation and pulmonary vein isolationExperimentalRF Atrial flutter ablation and pulmonary vein isolation using cryoablation
Receives: Procedure: Atrial flutter ablation and pulmonary vein isolation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter

    Main endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation as documented by an ECG or a R-test. Sustained AF episodes of more than a minute will be classified depending if they are symptomatic or not.

    Measured: an average of 24 months following the ablation procedure

Secondary outcomes (6)

  1. Recurrence rate of typical atrial flutter

    Recurrence rate of typical atrial flutter

    Measured: an average of 24 months following the ablation procedure

  2. Rate of occurrence of atypical flutter

    Occurrence rate of atypical flutter defined as a continuous atrial activity (with no return to the isoelectric line)in at least one lead, whose ECG appearance of F waves is different from that of a typical flutter

    Measured: an average of 24 months following the ablation procedure

  3. Rate of occurrence of atrial tachycardia

    Rate of occurrence of atrial tachycardia defined as an atrial activaty that generates a P wave with return to the isoelectric line in all leads

    Measured: an average of 24 months following the ablation procedure

  4. Rate of complications related to the ablation procedure

    The following complications will be considered:

    Hematoma at punction site, Thromboembolic accident, Tamponnade, Phrenic nerve paralysis, Symptomatic stenosis of pulmonary vein, Atrio-ventricular block Atrioesophageal fistula

    Measured: an average of 3 months after the ablation procedure

  5. Rate of major cardiovascular events

    Rate of major cardiovascular events such as rehospitalization for arrhythmia, heart failure, or embolic accident

    Measured: an average of 24 months following the ablation procedure

  6. All mortality rate

    All mortality rate (including sudden death and any type of death)

    Measured: an average of 24 months following the ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionApr 2018
  4. Study completionApr 2018

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01521988
Sponsor's protocol ID
2011/089/HP
Acronym
PAF CRIOBLAF
Status last verified
May 2018
First submitted
28 Nov 2011
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Anselme F, Savoure A, Clementy N, Cesari O, Pavin D, Jesel L, Defaye P, Boveda S, Rivat P, Mansourati J, Mechulan A, Cebron JP, Lande G, Bubenheim ScD M, Milhem A. Preventing atrial fibrillation by combined right isthmus ablation and cryoballoon pulmonary vein isolation in patients with typical atrial flutter: PAF-CRIOBLAF study. J Arrhythm. 2021 Aug 28;37(5):1303-1310. doi: 10.1002/joa3.12626. eCollection 2021 Oct.

    PubMed 34621429

Questions about this trial

What is this clinical trial studying?

A study testing Atrial flutter ablation and Atrial flutter ablation and pulmonary vein isolation in people with Atrial Flutter and Atrial Fibrillation, run by University Hospital, Rouen at 15 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 6 inclusion and 13 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter (time frame: an average of 24 months following the ablation procedure). 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 NCT01521988, which also lists 1 linked publication.

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 6 Nov 2026.

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