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PV Cryoablation Efficacy (COR ADVANCE Study)

NCT02588183 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-06-08

No results posted yet for this study

Summary

The COR advance study is a non-randomized prospective single center study to assess the results of an electrophysiologically guided approach for PV cryoablation using the Arctic Front Advance ST® catheter together with the Achieve® mapping catheter in 25 patients with drug-refractory paroxysmal AF.

Methods Patient selection criteria will be the same that in the original COR study. All patients will be followed with a Reveal LINQ® cardiac monitor that will be implanted before ablation. The primary objective is the proportion of patients remaining free from atrial fibrillation recurrences without taking antiarrhythmic drugs 12 months after ablation. Secondary objectives are: AF-free survival without anti arrhythmic drugs 12 months after ablation, cumulative AF burden (number of AF episodes and percentage of time in AF) 12 months after ablation, percentage of the pulmonary veins with bidirectional block at the end of the procedure, and ablation time (from the onset of the first energy delivery to the end of the last energy delivery), procedure time (from femoral puncture to catheter removal), and fluoroscopy time.

Final results will be known 24 months after the first enrollment. Statistical analysis Continuous variables that are distributed normally according to the Shapiro-Wilk test will be presented as the mean \[standard deviation\], and the values will be compared with the t test. Continuous variables that do not follow a normal distribution will be presented as the median \[25th to 75th percentile\] and will be compared with the Mann-Whitney U test. Categorical variables between two groups with expected values \<5 will be compared with the Fisher exact test. Otherwise, categorical variables will be compared with the chi-squared test. The AF-free survival functions will be represented as Kaplan-Meier curves. Data analyses will be done with JMP® (version 9.0.1, SAS Institute Inc., Cary, NC, USA) and Stata® (version 11.0, StataCorp LP; College Station, TX, USA).

Conditions

Interventions

DEVICE

ArticFont Advance ST Cryoenergy Balloon Catheter

PV isolation using the ArticFont Advance ST Cryoenergy Balloon Catheter

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-03-31
Completion
2018-03-22

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02588183 on ClinicalTrials.gov