PV Cryoablation Efficacy (COR ADVANCE Study)

NCT02588183 | Completed

• 1 other identifier: AF-3064: COR ADVANCE Study
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; pulmonary vein; cryoenergy; cryoablation; ArcticFront

Outcome Measures

Primary Outcomes (1)

• Proportion of patients free-from AF, without antiarrhythmic drug therapy

  12 months

Secondary Outcomes (4)

• AF-free survival, without antiarrhythmic drug therapy

  12 months

• Proportion of PV with bidirectional block

  intraoperative

• Time required to complete isolation (LA time)

  intraoperative

• Cumulative AF burden

  12 months

Study Arms (1)

ArticFont Advance ST

EXPERIMENTAL

Patients undergoing PV isolation with the ArticFont Advance ST Cryoenergy Balloon Catheter

Device: ArticFont Advance ST Cryoenergy Balloon Catheter

Interventions

ArticFont Advance ST Cryoenergy Balloon Catheter DEVICE

PV isolation using the ArticFont Advance ST Cryoenergy Balloon Catheter

ArticFont Advance ST

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic recurrent paroxysmal AF
• \>2 episodes in the last 6 months
• Refractory to 1 or more antiarrhythmic drugs
• Anatomical pattern consisting of 4 pulmonary veins
• Willing and capable of providing informed consent

You may not qualify if:

• Patients that are \<18 or \>75 years old
• Prior AF ablation
• Prior cardiac surgery
• Moderate to severe valvular heart disease
• Anteroposterior diameter of the left atrium \>50 mm
• Hyperthyroidism, intracardiac thrombus, contraindications for anticoagulation, concomitant acute illness, pregnancy.
• Unavailability for follow-up at our center for at least 1 year

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Unidad de Arritmias, Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (1)

• Perez-Castellano N, Fernandez-Cavazos R, Moreno J, Canadas V, Conde A, Gonzalez-Ferrer JJ, Macaya C, Perez-Villacastin J. The COR trial: a randomized study with continuous rhythm monitoring to compare the efficacy of cryoenergy and radiofrequency for pulmonary vein isolation. Heart Rhythm. 2014 Jan;11(1):8-14. doi: 10.1016/j.hrthm.2013.10.014. Epub 2013 Oct 5.

  PMID: 24103221 RESULT

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FEA

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 22, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

ES (1)