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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
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Pulmonary vein isolation with cryoballoon catheter Not Applicable

Detailed 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.)


  3. 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:

    1. Volumes at P-wave onset and end-systole
    2. LA active emptying volume
    3. LA active emptying fraction
    4. Late diastolic peak velocity
    5. LA filling fraction
    6. Pulmonary venous inflow pattern

  4. 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.

  5. 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

  6. 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')


Secondary Outcome Measures :
  1. 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

  2. Atrial Flutter [ Time Frame: 3 months ]
    1. Flutter Acute Procedural Success 2. Freedom from Flutter Chronic Treatment Failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 β-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.
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Vivek Reddy
Investigators
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Principal Investigator: Vivek Y Reddy, MD Icahn School of Medicine at Mount Sinai
More Information
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Publications:
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.
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.

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Responsible Party: Vivek Reddy, DIRECTOR CARDIAC ARRHYTHMIA SERVICE, PROFESSOR OF MEDICINE, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00821015    
Other Study ID Numbers: GCO 09-0628
First Posted: January 12, 2009    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
cryoablation
recurring arrhythmia
stroke
RF ablation
 LA ablation
nodal ablation
catheter ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes