Effect of Balloon Cryoablation on Left Atrial Function (CRYO-LA)
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|ClinicalTrials.gov Identifier: NCT00821015|
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Atrial fibrillation is a common and disabling irregular heart rhythm, that affects 1 to 1.5 million Americans. Recent clinical experience with the Medtronic Arctic Front™ Cardiac CryoAblation Catheter System suggests that it can be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF, thereby reducing or eliminating the recurrence of AF.3-4 However, the very large ablative surface of this balloon ablation catheter raises the possibility that this technique may damage extensive areas of the atrial myocardium.
The LA is an elastic chamber, designed to expand and contract with ease to accommodate the influx and outflow of blood, while maintaining relatively low pressure. When exposed to stress or injury, whether acute or chronic, the LA may lose much of its elasticity, resulting in overall dilation accompanied by fibrosis in some cases. Overall, this may potentially result in diminution of LA mechanical function (both systolic contractile function, and diastolic relaxation function). In addition, LA function is linked to both Left Ventricular (LV) systolic and diastolic function, manifesting in an overall impact on cardiac remodeling, including the area of the pulmonary vein ostia, and a significant decrease in LV ejection fraction (LVEF). On the other hand, the positive effects of maintaining sinus rhythm with successful catheter ablation of AF may result in improvement of LA mechanical function.5-9
Based on the potentially deleterious effects of damage caused by cryoablation, to the atrial myocardium during balloon ablation, this prospective, non-randomized, single-center study has been designed to assess the atrial effects of balloon cryo-ablation.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Pulmonary vein isolation with cryoballoon catheter||Not Applicable|
This study is a prospective, non-randomized, single-center, controlled study of patients with AF referred for ablation after failing one or more Class I-IV antiarrhythmic drugs used in the treatment of AF.
• All study subjects will undergo cryoablation.
Subjects will be followed for 12 months to assess the chronic impact of ablation with the Medtronic CryoCath Arctic Front™ Cardiac CryoAblation Catheter System on LA and LV mechanical function. In addition, patients will undergo scheduled and symptom-driven assessments to detect recurrent AF and adverse events (AEs).
We will evaluate the effect of ablation with the Medtronic Arctic Front™ Cardiac CryoAblation Catheter System on the atrial myocardium, with respect to LA (and LV) mechanical function, by assessing images acquired using TTE and CT in adult patients with atrial fibrillation who have failed at least one anti-arrhythmic drug. The efficacy of the Arctic Front™ Cardiac CryoAblation Catheter System will be assessed by ambulatory continuous ECG monitoring
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Balloon Cryoablation on Left Atrial Function (CRYO-LA)|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||June 2012|
All study subjects will undergo cryoablation. This is a non-randomized trial.
Device: Pulmonary vein isolation with cryoballoon catheter
For each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient.
- Number of Participants With Acute Procedural Success (APS) [ Time Frame: Immediately following procedure ]Acute Procedural Success (APS) is the demonstration of electrical isolation of all 4 PVs or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
- Number of Participants With AF Recurrence [ Time Frame: 6 months and 12 months ]
Number of Participants with AF Recurrence at 6 months and at 12 months after Cryoballoon Ablation for Atrial Fibrillation.
(Chronic Treatment Success is defined as a subject who does not have episodes of AF, lasting at least 30 seconds in duration, 3 months following the initial ablation procedure.)
- Left Atrial Measurements [ Time Frame: Baseline and 6 months ]
Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF
Parameters of atrial function:
- Volumes at P-wave onset and end-systole
- LA active emptying volume
- LA active emptying fraction
- Late diastolic peak velocity
- LA filling fraction
- Pulmonary venous inflow pattern
- LVEF [ Time Frame: Baseline and 6 months ]Ventricular Function measured by Left Ventricular Ejection Function (LVEF). A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%. An LVEF of 65%, for example means that 65% of total amount of blood in the left ventricle is pumped out with each heartbeat.
- Left Atrial Volume [ Time Frame: Baseline and 6 months ]Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF
- Deflections of the Mitral Annulus Measurement [ Time Frame: Baseline and 6 months ]Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF Deflections of the mitral annulus as measured by peak early ventricular diastolic velocity (E'), and during atrial contraction (A')
- Chronic Treatment Success for the Follow-up Visit Within Treatment Windows. [ Time Frame: 3 months ]Chronic Treatment Success for the follow-up visit within treatment windows. 1. Whether on or off Atrial Fibrillation Drugs (AFDs) during the Non-blanked Follow-up Period 2. When off Atrial Fibrillation Drugs
- Atrial Flutter [ Time Frame: 3 months ]1. Flutter Acute Procedural Success 2. Freedom from Flutter Chronic Treatment Failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821015
|Principal Investigator:||Vivek Y Reddy, MD||Icahn School of Medicine at Mount Sinai|