Junctional AV Ablation in CRT-D: JAVA-CRT | NCT02946853

NCT02946853

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRT-D	Active Comparator	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).	Device: Cardiac resynchronization therapy - defibrillator
CRT-D and AVJ Ablation	Experimental	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.	Procedure: Atrioventricular junctional (AVJ) ablation Device: Cardiac resynchronization therapy - defibrillator

Name	Type	Description	Arm Group Labels	Other Names
Atrioventricular junctional (AVJ) ablation	Procedure	RF energy delivery to AV node to create complete AV block	CRT-D and AVJ Ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)	Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.	Baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Left Ventricular Ejection Fraction (EF)	Change in left ventricular ejection fraction from baseline to 6 months. Units are expressed in percent and change may vary from -20% to 20%. More negative numbers are desired representing improvement from baseline to 6 months.	Baseline to 6 months

Other Outcomes

Measure	Description	Time Frame
Percent Change in Left Ventricular End-diastolic Volume (LVEDV)	Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.	Baseline to 6 months
Number of Patients With Heart Failure Hospitalizations

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jonathan S Steinberg, MD	University of Rochester	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Cardiology		Little Rock	Arkansas	72205	United States
Huntington Memorial Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35043250	Derived	Steinberg JS, Gorcsan J, Mazur A, Jain SK, Rashtian M, Greer GS, Zarraga I, Vloka M, Cook MM, Salam T, Mountantonakis S, Beck H, Silver J, Aktas M, Henrikson C, Schaller RD, Epstein AE, McNitt S, Schleede S, Peterson D, Goldenberg I, Zareba W. Junctional AV ablation in patients with atrial fibrillation undergoing cardiac resynchronization therapy (JAVA-CRT): results of a multicenter randomized clinical trial pilot program. J Interv Card Electrophysiol. 2022 Aug;64(2):519-530. doi: 10.1007/s10840-021-01116-6. Epub 2022 Jan 18.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 26, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Number of patients with heart failure hospitalizations in each arm of the study.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
BG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00072(66 to 78) BG00173(65 to 81) BG00273(65 to 81)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0014 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00011 BG00113 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00013 BG00113 BG002

LV End Systolic Volume

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000115± 29 BG001121± 39 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)

Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.

Some patients did not undergo outcome measures due to inability to come for follow-up due to COVID-19.

Posted

Count of Participants

Participants

Baseline to 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants	OG00010 OG00112

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0016

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		1.00		Odds Ratio (OR)	1.00			2-Sided	95	0.14	7.21					Superiority

Secondary

Change in Left Ventricular Ejection Fraction (EF)

Change in left ventricular ejection fraction from baseline to 6 months. Units are expressed in percent and change may vary from -20% to 20%. More negative numbers are desired representing improvement from baseline to 6 months.

A small number patients were unable to return for follow-up due the the outbreak of COVID-19 and some outcome measures were not completed.

Posted

Mean

Standard Deviation

percentage

Baseline to 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units

Other Pre-specified

Percent Change in Left Ventricular End-diastolic Volume (LVEDV)

Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.

Posted

Mean

Standard Deviation

% change in volume

Baseline to 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants	OG000

Other Pre-specified

Number of Patients With Heart Failure Hospitalizations

Number of patients with heart failure hospitalizations in each arm of the study.

Posted

Number

participants

Baseline to 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants	OG000

Other Pre-specified

Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy

Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study

Posted

Number

participants

Baseline to 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants

Other Pre-specified

Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF

Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.

Posted

Count of Participants

Participants

Baseline to 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants

Other Pre-specified

Percentage of Biventricular Pacing

Amount of time that CRT is delivered

Posted

Mean

Standard Deviation

% BiV pacing

At 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants	OG000

Other Pre-specified

Kansas City Cardiomyopathy Questionnaire

Scoring scale from 0 to 100. Higher scores represent better quality of life.

Posted

Mean

Standard Deviation

score on a scale

Baseline and 6 months

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD

Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.

Posted

Number

participants

Baseline to one month

ID	Title	Description
OG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation
OG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CRT-D	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation	1	13	1	13	0	13
EG001	CRT-D and AVJ Ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation	0	13	1	13	0	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hospitalization with heart failure	Cardiac disorders		Non-systematic Assessment		EG0001 events1 affected13 at risk EG0011 events1 affected13 at risk

The study results were hampered by difficulty meeting the sample size targets, resulting in lower than planned power and precision. In addition, the trial did not have a study arm without any intervention (either CRT or AVJA) so that "untreated" patients could be compared to each intervention group. Hard clinical endpoints including hospitalization, death and ICD events were too infrequent to make meaningful comparisons.

Certain Agreements

ID	Term
D054143	Heart Failure, Systolic
D001281	Atrial Fibrillation

ID	Term
D006333	Heart Failure
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms