Trial Outcomes & Findings for Junctional AV Ablation in CRT-D: JAVA-CRT (NCT NCT02946853)
NCT ID: NCT02946853
Last Updated: 2022-01-25
Results Overview
Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2022-01-25
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Junctional AV Ablation in CRT-D: JAVA-CRT
Baseline characteristics by cohort
| Measure |
CRT-D
n=13 Participants
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
|
CRT-D and AVJ Ablation
n=13 Participants
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
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=99 Participants
|
73 years
n=107 Participants
|
73 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
LV End Systolic Volume
|
115 cc
STANDARD_DEVIATION 29 • n=99 Participants
|
121 cc
STANDARD_DEVIATION 39 • n=107 Participants
|
118 cc
STANDARD_DEVIATION 30 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Some patients did not undergo outcome measures due to inability to come for follow-up due to COVID-19.
Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.
Outcome measures
| Measure |
CRT-D
n=10 Participants
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
|
CRT-D and AVJ Ablation
n=12 Participants
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
|
|---|---|---|
|
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CRT-D
n=10 Participants
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
|
CRT-D and AVJ Ablation
n=12 Participants
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
|
|---|---|---|
|
Change in Left Ventricular Ejection Fraction (EF)
|
-7.0 percentage
Standard Deviation 11.8
|
-8.6 percentage
Standard Deviation 9.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 monthsPercent change in left ventricular end-diastolic volume (LVEDV) by study arm.
Outcome measures
| Measure |
CRT-D
n=12 Participants
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
|
CRT-D and AVJ Ablation
n=10 Participants
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
|
|---|---|---|
|
Percent Change in Left Ventricular End-diastolic Volume (LVEDV)
|
-1.1 % change in volume
Standard Deviation 23.7
|
-3.5 % change in volume
Standard Deviation 13.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 monthsNumber of patients with heart failure hospitalizations in each arm of the study.
Outcome measures
| Measure |
CRT-D
n=13 Participants
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
|
CRT-D and AVJ Ablation
n=13 Participants
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
|
|---|---|---|
|
Number of Patients With Heart Failure Hospitalizations
|
1 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 monthsNumber of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study
Outcome measures
| Measure |
CRT-D
n=13 Participants
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
|
CRT-D and AVJ Ablation
n=13 Participants
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
|
|---|---|---|
|
Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 monthsNumber of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.
Outcome measures
| Measure |
CRT-D
n=13 Participants
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
|
CRT-D and AVJ Ablation
n=13 Participants
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
|
|---|---|---|
|
Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 6 monthsAmount of time that CRT is delivered
Outcome measures
| Measure |
CRT-D
n=13 Participants
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
|
CRT-D and AVJ Ablation
n=13 Participants
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
|
|---|---|---|
|
Percentage of Biventricular Pacing
|
77.1 % BiV pacing
Standard Deviation 26.3
|
97.7 % BiV pacing
Standard Deviation 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsScoring scale from 0 to 100. Higher scores represent better quality of life.
Outcome measures
| Measure |
CRT-D
n=13 Participants
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
|
CRT-D and AVJ Ablation
n=13 Participants
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
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire
Baseline
|
56.6 score on a scale
Standard Deviation 17.6
|
61.9 score on a scale
Standard Deviation 26.9
|
|
Kansas City Cardiomyopathy Questionnaire
6 months
|
69.1 score on a scale
Standard Deviation 20.3
|
81.3 score on a scale
Standard Deviation 18.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to one monthEpisodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.
Outcome measures
| Measure |
CRT-D
n=13 Participants
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
|
CRT-D and AVJ Ablation
n=13 Participants
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
|
|---|---|---|
|
Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD
|
1 participants
|
0 participants
|
Adverse Events
CRT-D
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
CRT-D and AVJ Ablation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRT-D
n=13 participants at risk
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
|
CRT-D and AVJ Ablation
n=13 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Hospitalization with heart failure
|
7.7%
1/13 • Number of events 1 • Baseline to 6 months
|
7.7%
1/13 • Number of events 1 • Baseline to 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place