Paroxysmal Atrial Fibrillation Ablation: complex fractionated atrial electrograms ablation in addition to pulmonary vein isolation versus pulmonary vein isolation

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001231639
• Date of registration: 25/11/2014
• Prospective Registration: No
• Primary sponsor: Massimiliano Faustino
• Public title: Paroxysmal Atrial Fibrillation Ablation: complex fractionated atrial electrograms ablation in addition to pulmonary vein isolation versus pulmonary vein isolation
• Scientific title: Patients with paroxysmal Atrial Fibrillation Ablation: complex fractionated atrial electrograms ablation in addition to pulmonary vein isolation versus pulmonary vein isolation alone on maintenance of sinus rhythm. (PAFA-SP)
• Date of first enrolment: 01/01/2007
• Target sample size: 150
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12614001231639.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;

Countries of recruitment

Italy

Contacts

• Name: Dr Massimiliano Faustino

• Name: Dr Massimiliano Faustino

Key inclusion & exclusion criteria

Inclusion criteria: The inclusion criteria is paroxysmal atrial fibrillation was defined accordingly to the Task Force for the Management of Atrial Fibrillation of ESC/ECATS 2007
Exclusion criteria: Persistent atrial fibrillation, permanent atrial fibrillation.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Paroxysmal atrial fibrillation;
Paroxysmal atrial fibrillation

Surgery - Surgical techniques

Cardiovascular - Other cardiovascular diseases

Intervention(s)

Pulmonary vein isolation (PVI) during paroxysmal Atrial Fibrillation (75 patients): During the procedure, 4 catheters were introduced via the right femoral vein under lidocaine local anesthesia. A decapolar catheter (InquiryTM St. Jude Medical Inc., St.Paul, MN, USA) was positioned inside the coronary sinus (CS) and a tetrapolar catheter (SupremeTM CRD-2, St. Jude Medical Inc., St.Paul, MN, USA) on the His bundle. Left atrium access was obtained by a single interatrial septal puncture with a BRK needle (St. Jude Medical Inc., St.Paul, MN, USA). Subsequently a circumferential decapolar catheter for pulmonary vein mapping (AFocusIITM 10 pole with a 20 mm diameter; St. Jude Medical Inc., St.Paul, MN, USA) , and the ablation catheter as were positioned into the left atrium.
The ablation was performed with open irrigated ablation catheter Therapy Cool Path DuoTM (St. Jude Medical Inc., St.Paul, MN, USA). 3-D electroanatomic mapping was performed using EnSite NavXTM-software version 8.0 (St. Jude Medical Inc., St.Paul, MN, USA). The time of the procedure never exceeded four hours.
The first objective was to systematically isolate all segmental ostial pulmonary veins. Pulmonary vein isolation was confirmed by entrance block.
Repeated electrophysiological procedures were carried out for recurrent atrial arrhythmias (after the blanking period or 3 months). The first objective was to assess pulmonary vein reconduction, followed by electrical re-isolation.

Primary Outcome(s)

Outcome of atrial fibrillation ablation after pulmonary vein isolation or a stepwise approach.

"Procedure success" is defined as freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) off antiarrhythmic drug during follow-up after first and second ablation.
"Procedure failure" is defined as atrial arrhythmia recurrence during follow-up .

The primary outcome of the study was freedom from AF recurrency 3 and 12 months after ablation (excluding the pre-specified blanking period from months 0 to 3). Evaluation included assessment of arrhythmia-related symptoms, adverse events, treatment adherence and any additional therapy since the previous follow-up visit and a 12-lead electrocardiogram. A 48-hour Holter monitoring was also performed every month, and in addition to clinical examinations (the questionnaire was designed for this study), a structured questionnaire was administered to record arrhythmia recurrence and any other symptom.[Time Frame: After first and second catheter ablation, all patients were followed up in our outpatient clinic at 1week, 2 weeks, 1 month, 2,3,6 and 12 months]

Secondary Outcome(s)

In patients who experience "procedure failure" (defined above), a re-do ablation may be performed. Then the patients will be followed-up again for atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) recurrence.Evaluation included assessment of arrhythmia-related symptoms, adverse events, treatment adherence and any additional therapy since the previous follow-up visit and a 12-lead electrocardiogram. A 48-hour Holter monitoring was also performed every month, and in addition to clinical examinations (the questionnaire was designed for this study), a structured questionnaire was administered to record arrhythmia recurrence and any other symptom. [After first and second catheter ablation, all patients were followed up in our outpatient clinic at 1week, 2 weeks, 1 month, 2,3,6 and 12 months]

Secondary ID(s)

none

Ethics review

Status: Approved
Approval date:
Contact:

Azienda USL Pescara