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

NCT01521988 | Completed DMC

• 1 other identifier: 2011/089/HP
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 15

Brief 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 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.

• 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.

Conditions

Atrial Flutter; Atrial Fibrillation

Keywords

Atrial flutter; Atrial fibrillation; Catheter ablation

Outcome Measures

Primary Outcomes (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.

  an average of 24 months following the ablation procedure

Secondary Outcomes (6)

• Recurrence rate of typical atrial flutter

  an average of 24 months following the ablation procedure

• Rate of occurrence of atypical flutter

  an average of 24 months following the ablation procedure

• Rate of occurrence of atrial tachycardia

  an average of 24 months following the ablation procedure

• Rate of complications related to the ablation procedure

  an average of 3 months after the ablation procedure

• Rate of major cardiovascular events

  an average of 24 months following the ablation procedure

Study Arms (2)

Atrial flutter ablation

ACTIVE COMPARATOR

RF atrial flutter ablation

Procedure: Atrial flutter ablation

Atrial flutter ablation and pulmonary vein isolation

EXPERIMENTAL

RF Atrial flutter ablation and pulmonary vein isolation using cryoablation

Procedure: Atrial flutter ablation and pulmonary vein isolation

Interventions

Atrial flutter ablation PROCEDURE

Radiofrequency ablation of Atrial flutter

Atrial flutter ablation

Atrial flutter ablation and pulmonary vein isolation PROCEDURE

Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation

Atrial flutter ablation and pulmonary vein isolation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• History of mitral valve surgery
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Medtronic: collaborator

Study Sites (15)

CHU de Brest

Brest, France

Location

CHU Grenoble

Grenoble, 38000, France

Location

CH La Rochelle

La Rochelle, France

Location

AP-HM - Hôpital Nord

Marseille, France

Location

Hôpital Privé de Clairval

Marseille, France

Location

CHU de Nantes

Nantes, France

Location

Nouvelles Cliniques Nantaises

Nantes, France

Location

CHU de Rennes

Rennes, 35033, France

Location

University Hospital of Rouen

Rouen, 76000, France

Location

CHU de Strasbourg

Strasbourg, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHU de Tours

Tours, France

Location

Clinique Saint Gatien

Tours, France

Location

Clinique Saint Joseph

Trélazé, France

Location

Polyclinique Vauban

Valenciennes, France

Location

MeSH Terms

Conditions

Atrial Flutter; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederic Anselme, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: January 31, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Locations

FR (15)