Effect of Balloon Cryoablation on Left Atrial Function

Atrial Fibrillation Clinical Trial

— CRYO-LA  

Official title:

Effect of Balloon Cryoablation on Left Atrial Function (CRYO-LA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821015
• Other study ID #: GCO 09-0628
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Documented paroxysmal atrial fibrillation

• = 18 and = 85 years of age

• Failure of one or more AF Drugs (AFDs).

• Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation

• Ability to understand the requirements of the study

• Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion Criteria:

• Any reversible cause of AF (post-surgery, thyroid disorder, etc.)

• More than 4 cardioversions in the prior year.

• Patients with recent myocardial infarction (less than 2 months) or unstable angina.

• Patients with congestive heart failure (NYHA class III or IV).

• Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.

• Women who are known to be pregnant or have had a positive ß-HCG test 7 days prior to procedure.

• Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).

• Patients whose life expectancy is less than one year.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vivek Reddy

References & Publications (9)

European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia Scoiety (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic Surgeons (STS), Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ. HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007 Jun;4(6):816-61. Epub 2007 Apr 30. Review. Erratum in: Heart Rhythm. 2009 Jan;6(1):148. — View Citation

Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. Erratum in: Circulation. 2007 Aug 7;116(6):e138. — View Citation

Lemola K, Desjardins B, Sneider M, Case I, Chugh A, Good E, Han J, Tamirisa K, Tsemo A, Reich S, Tschopp D, Igic P, Elmouchi D, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effect of left atrial circumferential ablation for atrial fibrillation on left atrial transport function. Heart Rhythm. 2005 Sep;2(9):923-8. — View Citation

Reant P, Lafitte S, Jaïs P, Serri K, Weerasooriya R, Hocini M, Pillois X, Clementy J, Haïssaguerre M, Roudaut R. Reverse remodeling of the left cardiac chambers after catheter ablation after 1 year in a series of patients with isolated atrial fibrillation. Circulation. 2005 Nov 8;112(19):2896-903. Epub 2005 Oct 31. — View Citation

Reddy VY, Neuzil P, d'Avila A, Laragy M, Malchano ZJ, Kralovec S, Kim SJ, Ruskin JN. Balloon catheter ablation to treat paroxysmal atrial fibrillation: what is the level of pulmonary venous isolation? Heart Rhythm. 2008 Mar;5(3):353-60. doi: 10.1016/j.hrthm.2007.11.006. Epub 2007 Nov 7. — View Citation

Tsao HM, Wu MH, Huang BH, Lee SH, Lee KT, Tai CT, Lin YK, Hsieh MH, Kuo JY, Lei MH, Chen SA. Morphologic remodeling of pulmonary veins and left atrium after catheter ablation of atrial fibrillation: insight from long-term follow-up of three-dimensional magnetic resonance imaging. J Cardiovasc Electrophysiol. 2005 Jan;16(1):7-12. — View Citation

Van Belle Y, Janse P, Rivero-Ayerza MJ, Thornton AS, Jessurun ER, Theuns D, Jordaens L. Pulmonary vein isolation using an occluding cryoballoon for circumferential ablation: feasibility, complications, and short-term outcome. Eur Heart J. 2007 Sep;28(18):2231-7. Epub 2007 Jun 14. — View Citation

Verma A, Kilicaslan F, Adams JR, Hao S, Beheiry S, Minor S, Ozduran V, Claude Elayi S, Martin DO, Schweikert RA, Saliba W, Thomas JD, Garcia M, Klein A, Natale A. Extensive ablation during pulmonary vein antrum isolation has no adverse impact on left atrial function: an echocardiography and cine computed tomography analysis. J Cardiovasc Electrophysiol. 2006 Jul;17(7):741-6. — View Citation

Yamanaka K, Fujita M, Doi K, Tsuneyoshi H, Yamazato A, Ueno K, Zen E, Komeda M. Multislice computed tomography accurately quantifies left atrial size and function after the MAZE procedure. Circulation. 2006 Jul 4;114(1 Suppl):I5-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Acute Procedural Success (APS)	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.	Immediately following procedure
Primary	Number of Participants With AF Recurrence	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.)	6 months and 12 months
Primary	Left Atrial Measurements	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	Baseline and 6 months
Primary	LVEF	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.	Baseline and 6 months
Primary	Left Atrial Volume	Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF	Baseline and 6 months
Primary	Deflections of the Mitral Annulus Measurement	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')	Baseline and 6 months
Secondary	Chronic Treatment Success for the Follow-up Visit Within Treatment Windows.	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	3 months
Secondary	Atrial Flutter	1. Flutter Acute Procedural Success 2. Freedom from Flutter Chronic Treatment Failure	3 months