Trial Outcomes & Findings for Effect of Balloon Cryoablation on Left Atrial Function (NCT NCT00821015)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Immediately following procedure

Results posted on

2019-07-05

Participant Flow

Subjects presenting with AF for ablation recruited from the clinical practice of the Investigators.

Participant milestones

Participant milestones
Measure	Cryoballoon Catheter 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 Study STARTED	27
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Cryoballoon Catheter 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 Study Lost to Follow-up	12

Baseline Characteristics

Effect of Balloon Cryoablation on Left Atrial Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryoballoon Catheter n=27 Participants 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.
Age, Continuous	65 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Height	68.2 inches STANDARD_DEVIATION 4.22 • n=5 Participants
Weight	183.5 pounds STANDARD_DEVIATION 40.8 • n=5 Participants
Participants with Risk Factors Diabetes	1 Participants n=5 Participants
Participants with Risk Factors Hypertension	13 Participants n=5 Participants
Participants with Risk Factors Smoking	3 Participants n=5 Participants
Participants with Risk Factors Alcohol Abuse	0 Participants n=5 Participants
Participants with Risk Factors Coronary Artery Disease	4 Participants n=5 Participants
Participants with Risk Factors Myocardial Infarction	2 Participants n=5 Participants
Atrial Flutter	5 Participants n=5 Participants
Number of Prior Cardioversions	.66 cardioversions STANDARD_DEVIATION .09 • n=5 Participants
Number of Hospital Admissions for AF	.22 hospital admissions STANDARD_DEVIATION .08 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cryoballoon Catheter n=27 Participants 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.
Number of Participants With Acute Procedural Success (APS)	27 Participants

PRIMARY outcome

Timeframe: 6 months and 12 months

Population: Only subjects who returned for their visit was included in analysis

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.)

Outcome measures

Outcome measures
Measure	Cryoballoon Catheter n=26 Participants 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.
Number of Participants With AF Recurrence 6 months	3 Participants
Number of Participants With AF Recurrence 12 months	1 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Echocardiogram data was incomplete for 9 patients.

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

Outcome measures

Outcome measures
Measure	Cryoballoon Catheter n=18 Participants 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.
Left Atrial Measurements Parasternal baseline	3.79 cm Standard Deviation 0.55
Left Atrial Measurements Parasternal 6 months	3.77 cm Standard Deviation 0.54
Left Atrial Measurements Longitudinal baseline	5.70 cm Standard Deviation 0.72
Left Atrial Measurements Longitudinal 6 months	5.33 cm Standard Deviation 0.9
Left Atrial Measurements Transverse baseline	4.21 cm Standard Deviation 0.61
Left Atrial Measurements Transverse 6 months	3.82 cm Standard Deviation 0.95

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Echocardiogram data was incomplete for 9 patients.

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.

Outcome measures

Outcome measures
Measure	Cryoballoon Catheter n=18 Participants 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.
LVEF Baseline	59 percentage of blood Standard Deviation 0.05
LVEF 6 months	62 percentage of blood Standard Deviation 0.09

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Echocardiogram data was incomplete for 9 patients.

Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF

Outcome measures

Outcome measures
Measure	Cryoballoon Catheter n=18 Participants 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.
Left Atrial Volume End-Systolic Volume baseline	60.62 ml Standard Deviation 11.9
Left Atrial Volume End-Systolic Volume 6 months	54.71 ml Standard Deviation 36.08
Left Atrial Volume Pre-P Volume baseline	36.87 ml Standard Deviation 13.0
Left Atrial Volume Pre-P Volume 6 months	33.63 ml Standard Deviation 16.37
Left Atrial Volume End-Diastolic Volume baseline	25.69 ml Standard Deviation 24.12
Left Atrial Volume End-Diastolic Volume 6 months	24.08 ml Standard Deviation 54.69

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Echocardiographic data was incomplete for 9 participants

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')

Outcome measures

Outcome measures
Measure	Cryoballoon Catheter n=18 Participants 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.
Deflections of the Mitral Annulus Measurement E at baseline	64.00 cm/s Standard Deviation 16.75
Deflections of the Mitral Annulus Measurement E at 6 months	64.82 cm/s Standard Deviation 13.68
Deflections of the Mitral Annulus Measurement A at baseline	58.95 cm/s Standard Deviation 17.34
Deflections of the Mitral Annulus Measurement A at 6 months	54.18 cm/s Standard Deviation 14.04

SECONDARY outcome

Timeframe: 3 months

Population: Data about atrial fibrillation drugs during the 3 month period were unfortunately not collected for any participant in the study for this outcome measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data about atrial flutter procedural success were not collected for any participant in the study for this outcome measure.

1\. Flutter Acute Procedural Success 2. Freedom from Flutter Chronic Treatment Failure

Outcome measures

Outcome data not reported

Adverse Events

Cryoballoon Catheter

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cryoballoon Catheter n=27 participants at risk 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.
Eye disorders Central Retinal Artery Occlusion	3.7% 1/27

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vivek Y Reddy

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place