N/A Completed N=81 Randomized Single-blind Treatment

AF Substrate Mapping and Guided Ablation

Persistent Atrial Fibrillation

Source: ClinicalTrials.gov NCT02571218 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcomePrimary: Long-term Clinical Success Rate — 30; 21 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Long-term Clinical Success Rate	30; 21	—
SECONDARY Acute Ablation Procedure Outcome	12; 25	—

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02571218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.