This trial is active, not recruiting.

Condition persistent atrial fibrillation
Treatments substrate+mcpva, mcpva
Sponsor St. Jude Medical
Start date July 2015
End date December 2016
Trial size 80 participants
Trial identifier NCT02571218, CRD_785


In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
Subjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF.
The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.
Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.
The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.

Primary Outcomes

Long-term clinical success rate
time frame: 12 months

Secondary Outcomes

Acute ablation procedure outcome
time frame: intraoperative
Acute ablation procedure outcome
time frame: Within one hour after ablation procedure

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - 18 - 85 years of age - Persistent AF scheduled to undergo catheter ablation with approved standard indication by ESC/EHRA guidelines - First or second time ablation for persistent AF - Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule Exclusion Criteria: - Had two or more previous AF ablation procedures - Secondary AF - Hyperthyroidism - Left ventricular ejection fraction <30% - NYHA functional class IV - Left atrial area > 35 cm2 - Uncorrected severe valvular heart disease - Contraindication to anticoagulation - Presence of left atrial thrombus - Recent (<6 Months) myocardial Infarction or unstable angina or coronary artery by-pass - Thoracic surgery for congenital, valvular or aortic disease - History of cerebrovascular accidents - Pregnancy - Significant comorbidities such as cancer, severe renal insufficiency requiring hemodialysis, severe obstructive lung disease, cirrhosis, with a life expectancy less than 2 years

Additional Information

Official title Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation
Principal investigator Carlo Pappone, MD, PhD
Description This study is a prospective, single center, randomized, single-blind, controlled, 2-arm parallel group trial in Milan, Italy. The total duration of the study is expected to be 24 months with ~12 months of enrollment. Approximately 80 subjects suffering from persistent AF will be randomized in a 1:1 fashion to the following investigation arms: - Modified circumferential pulmonary vein ablation alone (mCPVA); - Substrate-targeted ablation guided by AF substrate mapping, followed by completion of modified circumferential pulmonary vein ablation (Substrate+ mCPVA) - Ablate the areas that have fast and regular electrical activities, starting from the fastest cycle length (defined by Mean CL in the range of 120-250 milliseconds, and SD CL in the range of 1-30 milliseconds - Ablate the areas that have consistent rotational or focal propagation pattern (defined by conduction velocity vectors) - Ablate the areas that comprises the slow conduction zone of possible arrhythmia circuits - If AF terminates during RF ablation, stimulation protocol will be used to examine if AF is re-inducible. If AF sustains or is re-inducible and physician decides to remap, mapping will be performed again for substrate-targeted ablation. If AF is not re-inducible, mCPVA will be completed Subjects will be followed up at 3, 6, 12 months. The primary objective of the study is to assess acute and long-term outcome of patient-tailored substrate-targeted ablation (Substrate) plus modified circumferential pulmonary vein ablation (Substrate+mCPVA) versus modified circumferential pulmonary vein ablation alone (mCPVA). The secondary objective of the study is to map and characterize electrophysiological substrates during AF, including regular and fast activities, complex fractionated electrograms, wave front propagation directions, and fibrosis.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.