Junctional AV Ablation in CRT-D: JAVA-CRT

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT02946853
• Collaborator: (none)
• Enrollment: 26
• Locations: 21
• Arms: 2
• Actual Duration (Months): 47
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication. However, many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately 30-36% of CRT patients are in atrial fibrillation (AF).

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure; Atrial Fibrillation (Permanent)	Procedure: Atrioventricular junctional (AVJ) ablation; Device: Cardiac resynchronization therapy - defibrillator	N/A

Detailed Description

This study is designed to evaluate if patients with AF indicated for CRT will have significant reduction in left ventricular end-systolic volume when randomized to atrioventricular junction (AVJ) ablation. In this study, subjects will be randomized to receive CRT-D or CRT-D with AVJ ablation. Randomization will be stratified by enrolling center (1:1 ratio).

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Junctional AV Ablation in CRT-D Patients With Atrial Fibrillation (JAVA-CRT Trial)
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CRT-D 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; Insertion of device capable of providing biventricular pacing and cardiac defibrillation; Other Names: CRT-D
Experimental: CRT-D and AVJ Ablation Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.	Procedure: Atrioventricular junctional (AVJ) ablation; RF energy delivery to AV node to create complete AV block; Device: Cardiac resynchronization therapy - defibrillator; Insertion of device capable of providing biventricular pacing and cardiac defibrillation; Other Names: CRT-D

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV) [Baseline to 6 months]

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

Secondary Outcome Measures

1. Change in Left Ventricular Ejection Fraction (EF) [Baseline to 6 months]

   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.

Other Outcome Measures

1. Percent Change in Left Ventricular End-diastolic Volume (LVEDV) [Baseline to 6 months]

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

2. Number of Patients With Heart Failure Hospitalizations [Baseline to 6 months]

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

3. Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy [Baseline to 6 months]

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

4. Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF [Baseline to 6 months]

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

5. Percentage of Biventricular Pacing [At 6 months]

   Amount of time that CRT is delivered

6. Kansas City Cardiomyopathy Questionnaire [Baseline and 6 months]

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

7. Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD [Baseline to one month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Optimal pharmacologic therapy is defined by published guidelines from the American Heart Association and the American College of Cardiology

• Initial implantation of CRT-D or prior implantation of CRT-D within one year

• Ischemic or nonischemic cardiomyopathy

• LVEF ≤ 35%

• NYHA class II-IV (ambulatory)

• QRS ≥ 120 ms for LBBB and ≥ 150 ms for non-LBBB patients

• Continuous AF > 3 months when no further efforts to restore sinus rhythm are feasible or pursued

Exclusion Criteria:

• Ventricular rate > 110 bpm at rest despite maximal medical therapy

• Ventricular rate < 50 bpm at rest

• Heart block/symptomatic bradycardia that necessitates permanent pacing

• Acute coronary syndrome or coronary artery bypass surgery within 12 weeks

• Severe aortic or mitral valvular heart disease

• Prior AVJ ablation

• Any medical condition likely to limit survival to < 1 year

• Patients with ACC/AHA Stage D refractory Class IV symptoms listed for transplant or requiring inotropic support

• Contraindication to systematic anticoagulation

• Renal failure requiring dialysis

• AF due to reversible cause e.g. hyperthyroid state

• Pregnancy

• Participation in other clinical trials that will affect the objectives of this study

• History of non-compliance to medical therapy

• Inability or unwillingness to provide informed consent

• Patients with short-lived AF or those in sinus rhythm are ineligible

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cardiology	Little Rock	Arkansas	United States	72205
2	Huntington Memorial Hospital	Pasadena	California	United States	91105
3	Emory Healthcare	Atlanta	Georgia	United States	30308
4	Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83704
5	University of Iowa	Iowa City	Iowa	United States	52242
6	Lahey Clinic	Burlington	Massachusetts	United States	01805
7	University of Massachusetts-Worchester	Worcester	Massachusetts	United States	01655
8	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan	United States	48073
9	Catholic Medical Ctr/New England Heart-Vasc Inst	Manchester	New Hampshire	United States	03102
10	SUNY at Buffalo	Buffalo	New York	United States	14203
11	Northwell Hospital	New York	New York	United States	10075
12	University of Rochester Medical Center	Rochester	New York	United States	14642
13	Oregon Health & Science University	Portland	Oregon	United States	97239
14	Portland VA Medical Center	Portland	Oregon	United States	97239
15	Abington Memorial Hospital	Abington	Pennsylvania	United States	19008
16	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19047
17	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
18	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
19	INOVA	Woodbridge	Virginia	United States	22191
20	Kootenai Heart Clinics, LLC	Spokane	Washington	United States	99204
21	Multicare Institute for Research and Innovation	Tacoma	Washington	United States	98405

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Jonathan S Steinberg, MD, University of Rochester

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 26, 2018

More Information

Publications

None provided.

• Responsible Party: Jonathan Steinberg, Professor of Medicine - Cardiology, University of Rochester
• ClinicalTrials.gov Identifier: NCT02946853
• Other Study ID Numbers: RSRB00060626
• First Posted: Oct 27, 2016
• Last Update Posted: Jan 25, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jonathan Steinberg, Professor of Medicine - Cardiology, University of Rochester: Atrial Fibrillation; CRT; AV Junction Ablation; LVESV
• Additional relevant MeSH terms: Atrial Fibrillation; Heart Failure, Systolic

Study Results

Participant Flow

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	13	13
COMPLETED	12	13
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	13	13	26
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	72	73	73
Sex: Female, Male (Count of Participants)
Female	3 23.1%	4 30.8%	7 26.9%
Male	10 76.9%	9 69.2%	19 73.1%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	11 84.6%	13 100%	24 92.3%
Region of Enrollment (participants) [Number]
United States	13 100%	13 100%	26 100%
LV End Systolic Volume (cc) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cc]	115 (29)	121 (39)	118 (30)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	10	12
Count of Participants [Participants]	5 38.5%	6 46.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.14 to 7.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Left Ventricular Ejection Fraction (EF)
Description	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.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	10	12
Mean (Standard Deviation) [percentage]	-7.0 (11.8)	-8.6 (9.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.974
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Other Pre-specified Outcome

Title	Percent Change in Left Ventricular End-diastolic Volume (LVEDV)
Description	Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	12	10
Mean (Standard Deviation) [% change in volume]	-1.1 (23.7)	-3.5 (13.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments	Some patients did not undergo 6 month echocardiogram due to restrictions related to COVID-19.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Other Pre-specified Outcome

Title	Number of Patients With Heart Failure Hospitalizations
Description	Number of patients with heart failure hospitalizations in each arm of the study.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	13	13
Number [participants]	1 7.7%	1 7.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.1 to 84.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Other Pre-specified Outcome

Title	Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy
Description	Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	13	13
Number [participants]	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Other Pre-specified Outcome

Title	Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF
Description	Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	13	13
Count of Participants [Participants]	1 7.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; 0.00 to 42.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Other Pre-specified Outcome

Title	Percentage of Biventricular Pacing
Description	Amount of time that CRT is delivered
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	13	13
Mean (Standard Deviation) [% BiV pacing]	77.1 (26.3)	97.7 (3.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.6
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Other Pre-specified Outcome

Title	Kansas City Cardiomyopathy Questionnaire
Description	Scoring scale from 0 to 100. Higher scores represent better quality of life.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	13	13
Baseline	56.6 (17.6)	61.9 (26.9)
6 months	69.1 (20.3)	81.3 (18.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.565
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	23.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Other Pre-specified Outcome

Title	Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD
Description	Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.
Time Frame	Baseline to one month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-D	CRT-D and AVJ Ablation
Arm/Group Description	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	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
Measure Participants	13	13
Number [participants]	1 7.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT-D, CRT-D and AVJ Ablation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; 0.0 to 42.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline to 6 months
Arm/Group Title	CRT-D		CRT-D and AVJ Ablation
Arm/Group Description	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		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
All Cause Mortality
	CRT-D		CRT-D and AVJ Ablation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		0/13 (0%)
Serious Adverse Events
	CRT-D		CRT-D and AVJ Ablation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		1/13 (7.7%)
Cardiac disorders
Hospitalization with heart failure	1/13 (7.7%)	1	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	CRT-D		CRT-D and AVJ Ablation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.