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| ID | Type | Description | Link |
|---|---|---|---|
| 10CRP3630033 | Other Grant/Funding Number | American Heart Association |
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Lack of funding
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis. Approximately half of all HF patients have electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a perturbation of the normal pattern of ventricular contraction that reduces the efficiency of ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF symptomatology in this subset of patients. Resynchronization of ventricular contraction is usually achieved through simultaneous pacing of the left and right ventricles using a biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial evidence supporting the use of BiV pacing in patients with prolonged QRS duration was obtained almost exclusively in patients with a left bundle-branch block (LBBB) electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular contraction in patients with LBBB can be obtained by univentricular left ventricular pacing with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that ventricular resynchronization can be obtained in subjects with right bundle-branch block (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac death. Most of these devices are currently programmed to avoid RV pacing. We aim to determine if ventricular resynchronization delivered through univentricular RV pacing improves symptoms in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD implantation for symptomatic heart failure. We further aim to determine if ventricular resynchronization improves myocardial performance and ventricular geometry as detected by echocardiographic measures and quality of life for patients with HF and RBBB. We hypothesize that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF symptoms, and positive ventricular remodeling in patients with HF and RBBB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVI-40 to RV DDD-40 to Bi-V DDD-40 | Experimental | Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40 |
|
| VVI-40 to Bi-V DDD-40 to RV DDD-40 | Experimental | Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40 |
|
| Bi-V DDD-40 to VVI-40 to RV DDD-40 | Experimental | Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40 |
|
| Bi-V DDD-40 to RV DDD-40 to VVI-40 | Experimental | Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVI-40 | Device | Pacing mode set to VVI-40, RV only pacing |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Echocardiographic Endpoints | Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure. | 6 months |
| Arrhythmic Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett D Atwater, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Durham VA Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | VVI-40 to RV DDD-40 to Bi-V DDD-40 | Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| FG001 | VVI-40 to Bi-V DDD-40 to RV DDD-40 | Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| FG002 | Bi-V DDD-40 to VVI-40 to RV DDD-40 | Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| FG003 | Bi-V DDD-40 to RV DDD-40 to VVI-40 | Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| FG004 | RV DDD-40 to VVI-40 to Bi-V DDD-40 | Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| FG005 | RV DDD-40 to Bi-V DDD-40 to VVI-40 | Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (6 Months) |
|
| ||||||||||||||||||
| Period 2 (6 Months) |
| |||||||||||||||||||
| Period 3 (6 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VVI-40 to RV DDD-40 to Bi-V DDD-40 | Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm. | All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period. | Posted | Number | percentage of participants | 6 months |
|
Adverse event data was collected over 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VVI-40 | VVI-40: Pacing mode set to VVI-40, RV only pacing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure Exacerbation, Heart Transplant | Cardiac disorders | Systematic Assessment |
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We were unable to enroll adequately, and the study was underpowered to assess either the safety or efficacy of RV only, or BIV pacing in patients with right bundle branch block.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett D. Atwater, MD | Duke University Medical Center | 9196848111 | brett.atwater@duke.edu |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
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| RV DDD-40 to VVI-40 to Bi-V DDD-40 | Experimental | Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40 |
|
| RV DDD-40 to Bi-V DDD-40 to VVI-40 | Experimental | Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40 |
|
| RV DDD-40 | Device | ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. |
|
| BiV DDD-40 | Device | ICD programmed to BiV pacing at a lower rate of 40 |
|
To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination. |
| 6 months |
| Minnesota Quality of Life Questionnaire | This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life. | 6 months |
| 6-minute Walk Distance | 6-minute walk distance was the distance that a participant could walk in 6 minutes. | 6 months |
| NYHA Function Class | The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest. | 6 months |
| Left Ventricular Ejection Fraction (LVEF) | 6 months |
| Left Ventricular End-diastolic Size | 6 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | VVI-40 to Bi-V DDD-40 to RV DDD-40 | Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| BG002 | Bi-V DDD-40 to VVI-40 to RV DDD-40 | Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| BG003 | Bi-V DDD-40 to RV DDD-40 to VVI-40 | Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| BG004 | RV DDD-40 to VVI-40 to Bi-V DDD-40 | Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| BG005 | RV DDD-40 to Bi-V DDD-40 to VVI-40 | Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40 VVI-40: Pacing mode set to VVI-40, RV only pacing RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG. BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40 |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| OG002 | Bi-V DDD-40 | Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing. |
|
|
| Secondary | Secondary Echocardiographic Endpoints | Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure. | Data not collected. | Posted | 6 months |
|
|
| Secondary | Arrhythmic Events | To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination. | All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Minnesota Quality of Life Questionnaire | This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life. | All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | 6-minute Walk Distance | 6-minute walk distance was the distance that a participant could walk in 6 minutes. | All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period. | Posted | Mean | Standard Deviation | meters | 6 months |
|
|
|
| Secondary | NYHA Function Class | The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Data not collected. | Posted | Mean | Standard Deviation | percent | 6 months |
|
|
|
| Secondary | Left Ventricular End-diastolic Size | Data not collected. | Posted | Mean | Standard Error | cubic cm | 6 months |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | RV DDD-40 | RV DDD-40: ICD programmed to DDD-40, RV only pacing with an AV interval producing QRS fusion on surface EKG. | 0 | 13 | 0 | 13 |
| EG002 | Bi-V DDD-40 | Bi-V DDD-40: ICD programmed to Bi-V pacing at a lower rate of 40 | 3 | 12 | 0 | 12 |
| Death | Infections and infestations |
|
| Death | Cardiac disorders |
|
Not provided
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |