Comparison of Treatment of Atrial Fibrillation (AF) Between Surgical Ultrasonic Technology or Drug Therapy for Patients With AF Requiring Mitral Valve Surgery

NCT01649544 | Terminated

• 2 other identifiers: 10080582011-A00275-36
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

Brief Summary

In pre-operative cardiac surgery, 30 to 40% of patients with mitral valvulopathy have had episodes of paroxysmal atrial fibrillation (PAF) or are in permanent or chronic atrial fibrillation (CAF). According to the 1999 PMSI data, close to 4000 mitral valve interventions were performed in France, in other words, more than 1000 patients present with this condition annually; despite a surgical correction of their valvulopathy, patients presenting with a pre-operative chronic atrial fibrillation remain in fibrillation following surgery despite treatment with anti-arrhythmic agents associated or not with a cardioversion. Thus, the survival rate without AF recurrence is 10% at 1 year and 5% at 2 years in patients with AF prior to surgery; on the other hand, patients in sinus rhythm at the time of surgery and without an antecedent of AF exhibit an incidence of no AF of 90% and 74% at 1 and 2 years, respectively. It has also been shown in numerous studies that the long-term morbidity in patients with atrial valve surgery is higher in those with AF. For more than 10 years, radio-frequency techniques using the endocavitary approach have shown a greater efficacy in maintaining sinus rhythm than drug therapy even though the techniques are invasive. These radio-frequency techniques were developed and tested during mitral surgery, but, to the investigators knowledge, there is only one randomized study that was carried out in a population with permanent AF using radio-frequency technique via the endocardial approach. Maintenance of sinus rhythm was obtained in only 44.4% of patients versus 4.5% in the control group; these results are not in accordance with the published prospective and retrospective registries using the technique peri-operatively. The principal problem of this study is the absence of medical treatment in the control group. In addition, the use of the radio-frequency technique requires an atriotomy resulting in a prolonged surgical time, which increases the peri-operative morbidity. Other simpler ablation techniques have been developed, such as the one using ultrasound. In comparison with the radio-frequency method, this latter technique presents numerous advantages including the absence of an atriotomy due to the fact that the epicardial pathway is used, a short procedure time (11 min on average), excellent reproducibility, the transmural character of the lesions, along with the simplicity of application. There is not, to the investigators knowledge, a randomized study comparing the peri-operative ultrasound technique (EPICOR) in mitral valve surgery with the conservative reference treatment, notably mitral valve surgery coupled with long-term amiodarone treatment. In effect, while amiodarone is the most efficacious anti-arrhythmic agent in the long-term, this drug is associated with a high percentage of significant side effects, close to 20% at 2 years. The only available results using the ultrasound technique are the registries pertaining to the follow-up of patients undergoing cardiac mitral or aortic surgery, with an antecedent of AF. The results appear to be encouraging with 85% of cases maintained in sinus rhythm at 12 months in the most recent studies. In this clinical context, a French multi-centric registry evaluated the peri-operative treatment of AF with all of the proposed techniques (cryotherapy, radio-frequency, and ultrasound). The percentage of maintenance of sinus rhythm appears to be lower than in the historical registries, at the level of 60%, but the techniques used in this registry were multiple even if 50% of patients were treated with ultrasound; in addition, there was no randomization and follow-up was only for 6 months.

Conditions

Mitral Valvulopathy; Atrial Fibrillation

Keywords

Mitral valvulopathy; Atrial Fibrillation; Amiodarone; Paroxysmal Atrial Fibrillation; Chronic Atrial Fibrillation; Ultrasound Technique

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation episode

  At least one episode of symptomatic AF or asymptomatic sustained \[\> 10 minutes\] documented by an ECG or an R-test changes, occurring between 3 months (after restoration of sinus rhythm by cardioversion if necessary at the end of the 2nd month) and 18th month

  At 18 months

Secondary Outcomes (4)

• Adverse drug effects of Amiodarone

  At 18 months

• major cardiovascular event

  At 18 months

• Atrial tachycardia

  At 18 months

• Death

  At 18 months

Study Arms (2)

EPICOR

EXPERIMENTAL

Cardiac ablation system EPICOR (CE n°0344). * ablation device EpicorTM UltraCinchTM LP (Class III device) * Positioning system and calibration EpicorTM LP (LP PASTM; device Class IIa) * Cable connection EpicorTM LP (unsterile) * Ablation Control System EpicorTM LP (Class IIb)

Device: EPICOR

Amiodarone

ACTIVE COMPARATOR

Cordarone : 400 mg/d during the 2 first months 200 mg/d from 3th to 18th month

Drug: Amiodarone

Interventions

EPICOR DEVICE

Intraoperatively, in addition to the usual gesture, it will be conducted a systematic exclusion-ligation of the left atrium and the establishment of electrodes atrial and ventricular pacing. The right pulmonary veins are isolated by dissection of the inter-atrial groove and application of the probe by biting on the atrial tissue, the procedure is identical on the left after dissection of the area between the left pulmonary artery and pulmonary veins. The use of ultrasound application will require 10 minutes to around the pulmonary veins using a multi-electrode probe set to deliver an output pulse from 15 to 100 Watts at a frequency from 3.5 to 4.6 MHz. Using EPICOR extends the operating time of 15 minutes.

EPICOR

Amiodarone DRUG

Amiodarone

Eligibility Criteria

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

You may qualify if:

• mitral valvulopathy requiring surgery
• paroxysmal atrial fibrillation or permanent or chronic atrial fibrillation
• Left atrium ≤ 55mm
• consent form signed

You may not qualify if:

• thyroid dysfunction
• pregnant
• contraindication of amiodarone

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (5)

CHU de Grenoble

Grenoble, France

Location

Hospices Civiles de Lyon

Lyon, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Heart Valve Diseases; Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Antoine DA COSTA, MD PhD

  CHU de Saint-Etienne

  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: July 23, 2012
• First Posted: July 25, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

FR (5)