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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Intervention Device: Pulmonary vein isolation with cryoballoon catheter
Enrollment 27
Recruitment Details Subjects presenting with AF for ablation recruited from the clinical practice of the Investigators.
Pre-assignment Details  
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Period Title: Overall Study
Started 27
Completed 15
Not Completed 12
Reason Not Completed
Lost to Follow-up             12
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
65  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
10
  37.0%
Male
17
  63.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 27 participants
68.2  (4.22)
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 27 participants
183.5  (40.8)
Participants with Risk Factors  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Diabetes
1
   3.7%
Hypertension
13
  48.1%
Smoking
3
  11.1%
Alcohol Abuse
0
   0.0%
Coronary Artery Disease
4
  14.8%
Myocardial Infarction
2
   7.4%
Atrial Flutter   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
5
  18.5%
[1]
Measure Description: Arrhythmia History - Atrial flutter
Number of Prior Cardioversions  
Mean (Standard Deviation)
Unit of measure:  Cardioversions
Number Analyzed 27 participants
.66  (.09)
Number of Hospital Admissions for AF  
Mean (Standard Deviation)
Unit of measure:  Hospital admissions
Number Analyzed 27 participants
.22  (.08)
1.Primary Outcome
Title Number of Participants With Acute Procedural Success (APS)
Hide Description 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.
Time Frame Immediately following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
27
 100.0%
2.Primary Outcome
Title Number of Participants With AF Recurrence
Hide Description

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.)

Time Frame 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects who returned for their visit was included in analysis
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
6 months Number Analyzed 26 participants
3
  11.5%
12 months Number Analyzed 19 participants
1
   5.3%
3.Primary Outcome
Title Left Atrial Measurements
Hide Description

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
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was incomplete for 9 patients.
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: cm
Parasternal baseline 3.79  (0.55)
Parasternal 6 months 3.77  (0.54)
Longitudinal baseline 5.70  (0.72)
Longitudinal 6 months 5.33  (0.9)
Transverse baseline 4.21  (0.61)
Transverse 6 months 3.82  (0.95)
4.Primary Outcome
Title LVEF
Hide Description 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.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was incomplete for 9 patients.
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percentage of blood
Baseline 59  (0.05)
6 months 62  (0.09)
5.Primary Outcome
Title Left Atrial Volume
Hide Description Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was incomplete for 9 patients.
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ml
End-Systolic Volume baseline Number Analyzed 18 participants
60.62  (11.9)
End-Systolic Volume 6 months Number Analyzed 18 participants
54.71  (36.08)
Pre-P Volume baseline Number Analyzed 15 participants
36.87  (13.0)
Pre-P Volume 6 months Number Analyzed 15 participants
33.63  (16.37)
End-Diastolic Volume baseline Number Analyzed 18 participants
25.69  (24.12)
End-Diastolic Volume 6 months Number Analyzed 18 participants
24.08  (54.69)
6.Primary Outcome
Title Deflections of the Mitral Annulus Measurement
Hide Description 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')
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiographic data was incomplete for 9 participants
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: cm/s
E at baseline Number Analyzed 18 participants
64.00  (16.75)
E at 6 months Number Analyzed 18 participants
64.82  (13.68)
A at baseline Number Analyzed 15 participants
58.95  (17.34)
A at 6 months Number Analyzed 15 participants
54.18  (14.04)
7.Secondary Outcome
Title Chronic Treatment Success for the Follow-up Visit Within Treatment Windows.
Hide Description 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
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data about atrial fibrillation drugs during the 3 month period were unfortunately not collected for any participant in the study for this outcome measure.
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Atrial Flutter
Hide Description 1. Flutter Acute Procedural Success 2. Freedom from Flutter Chronic Treatment Failure
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data about atrial flutter procedural success were not collected for any participant in the study for this outcome measure.
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description:

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cryoballoon Catheter
Hide Arm/Group Description

All study subjects will undergo cryoablation. This is a non-randomized trial.

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.

All-Cause Mortality
Cryoballoon Catheter
Affected / at Risk (%)
Total   0/27 (0.00%) 
Hide Serious Adverse Events
Cryoballoon Catheter
Affected / at Risk (%)
Total   1/27 (3.70%) 
Eye disorders   
Central Retinal Artery Occlusion *  1/27 (3.70%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cryoballoon Catheter
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Vivek Y Reddy
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-7114
EMail: vivek.reddy@mountsinai.org
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.
Layout table for additonal information
Responsible Party: Vivek Reddy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00821015    
Other Study ID Numbers: GCO 09-0628
First Submitted: January 9, 2009
First Posted: January 12, 2009
Results First Submitted: March 13, 2019
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019