Non Invasive Mapping Before Ablation for Atrial Fibrillation.

NCT02113761 | Completed DMC

• 1 other identifier: BE77201318160
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE / CONTEXT The ECG records the electrical activity propagating along cardiac cells (from the atria to the ventricles). The standard 12 ECG leads placed on the chest measure the global activation of the heart and do not have the ability to detect small-scale disturbances or to pinpoint ectopic activity. By the 1960s, multiple electrodes were placed around the chest to try to understand the complexity of the distribution of electrical activity in relation to the single cardiothoracic geometry of each individual. The safety of this method is similar to the ECG but its superiority has been demonstrated by the detection of anomalies imperceptible to the standard ECG. The accuracy of the technique in localizing rhythm disturbances is on the order of 5 mm. OBJECTIVES Main objective: To evaluate the utility of noninvasive mapping during persistent AF electrophysiology procedure Secondary objectives:

• Reduction in RF time compared to standard of care (historical control - comparable patient population)
• Reduction in procedure time compared to standard of care (historical control - comparable patient population)
• Freedom from persistent AF at the end of the 12 months F/U period STUDY SIZE The sample size was estimated at 100 patients, with up to 20 patients per center STUDY CENTERS 8 Centers :
• Brugmann - Brussels (Belgium)
• Clinique Pasteur - Toulouse (France)
• Medizinische Klinik und Poliklinik - Mainz (Germany)
• University ed Herzzentrum Freiburg Bad Kozingen (Germany)
• Deutsches Herzzentrum München, Munich (Germany)
• Kerkhoff Klinik, Bad Nauheim, (Germany)
• Sint-Jan Sint-Franciscus Xaverius, Brugge (Belgium)
• Clinique Ambroise Paré, Paris, France EXPECTED OUTCOME In patients referred for ablation of persistent AF, ECG mapping data will be correlated to the invasive procedure. It is expected that procedure time will be statistically shorter and total RF energy delivery is expected to be smaller than that of standard of care for AF treatment.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• radiofrequency duration

  Radiofrequency duration necessary to terminate atrial fibrillation and total radiofrequency duration

  1 day (At the end of the procedure)

• Atrial fibrillation termination

  Amount of patients with AF termination into sinus rhythm or atrial tachycardia during AF ablation.

  At the time of the procedure of catheter ablation

Secondary Outcomes (1)

• Atrial fibrillation recurrence

  One year

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with persistent atrial fibrillation as described by the Consensus Statement and with an indication for atrial fibrillation catheter ablation.

You may qualify if:

• Male or Female Adults (≥18 years old)
• Minors (15-18 years) of both sexes subject to parental consent or legal representative
• Persistent AF ablation refractory to drugs
• Persistent AF (as defined by consensus statement) for ≤ 12 month duration
• Consent signed by the patient after reading the information leaflet

You may not qualify if:

• Any previous left atrial (LA) ablation
• Any previous LA or RA surgery
• Current intra-cardiac thrombus
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Anteroposterior LA diameter \> 5.5 cm by TTE or CT
• Presence of any cardiac valve prosthesis
• Clinically significant mitral valve regurgitation or stenosis
• Myocardial infarction, PCI / PTCA or coronary artery stenting within the last 3 months
• Unstable angina
• Any cardiac surgery within the last 3 months
• NYHA class III or IV congestive heart failure
• Uncontrolled hyperthyroidism
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 months interval preceding the consent Date.
• Life expectancy less than one (1) year

Sponsors & Collaborators

• Brugmann University Hospital: lead
• Centre Hospitalier Universitaire Brugmann: collaborator

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PMD PhD

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: April 15, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 21, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

BE (1)