An interventional study of VVI-40 and RV DDD-40 in Heart Failure and Right Bundle-Branch Block, sponsored by Duke University. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 16 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: VVI-40 · Device: RV DDD-40 · Device: BiV 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
Device: VVI-40 · Device: RV DDD-40 · Device: BiV 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
Device: VVI-40 · Device: RV DDD-40 · Device: BiV DDD-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
Device: VVI-40 · Device: RV DDD-40 · Device: BiV 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
Device: VVI-40 · Device: RV DDD-40 · Device: BiV DDD-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
Device: VVI-40 · Device: RV DDD-40 · Device: BiV DDD-40
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 6 months
6-minute Walk Distance
6-minute walk distance was the distance that a participant could walk in 6 minutes.
Time frame: 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.
Time frame: 6 months
Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Left Ventricular End-diastolic Size
Time frame: 6 months
| Milestone | VVI-40 to RV DDD-40 to Bi-V DDD-40 | VVI-40 to Bi-V DDD-40 to RV DDD-40 | Bi-V DDD-40 to VVI-40 to RV DDD-40 | Bi-V DDD-40 to RV DDD-40 to VVI-40 | RV DDD-40 to VVI-40 to Bi-V DDD-40 | RV DDD-40 to Bi-V DDD-40 to VVI-40 |
|---|---|---|---|---|---|---|
| Started | 2 | 4 | 5 | 0 | 0 | 5 |
| Completed | 2 | 3 | 3 | 0 | 0 | 2 |
| Not completed | 0 | 1 | 2 | 0 | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 | 2 | 0 | 0 | 3 |
| Milestone | VVI-40 to RV DDD-40 to Bi-V DDD-40 | VVI-40 to Bi-V DDD-40 to RV DDD-40 | Bi-V DDD-40 to VVI-40 to RV DDD-40 | Bi-V DDD-40 to RV DDD-40 to VVI-40 | RV DDD-40 to VVI-40 to Bi-V DDD-40 | RV DDD-40 to Bi-V DDD-40 to VVI-40 |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 3 | 0 | 0 | 2 |
| Completed | 2 | 3 | 3 | 0 | 0 | 2 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | VVI-40 to RV DDD-40 to Bi-V DDD-40 | VVI-40 to Bi-V DDD-40 to RV DDD-40 | Bi-V DDD-40 to VVI-40 to RV DDD-40 | Bi-V DDD-40 to RV DDD-40 to VVI-40 | RV DDD-40 to VVI-40 to Bi-V DDD-40 | RV DDD-40 to Bi-V DDD-40 to VVI-40 |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 3 | 0 | 0 | 2 |
| Completed | 2 | 1 | 2 | 0 | 0 | 2 |
| Not completed | 0 | 2 | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 1 | 0 | 0 | 0 |
| percentage of participants | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| 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. | 0 | 29 | 20 |
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.
No measurements were reported for this outcome.
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.
| participants | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| Arrhythmic Events | 0 | 0 | 0 |
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.
| units on a scale | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| Minnesota Quality of Life Questionnaire | 39.3 ± 21.3 | 43.9 ± 20.3 | 55.78 ± 27.7 |
6-minute walk distance was the distance that a participant could walk in 6 minutes.
| meters | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| 6-minute Walk Distance | 292.4 ± 70.5 | 235.8 ± 122.8 | 244.44 ± 122 |
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.
| units on a scale | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| NYHA Function Class | 3.3 ± 0.7 | 3 ± 0.6 | 3.2 ± 0.9 |
| percent | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) | 24.8 ± 7.4 | 20 ± 9.7 | 22.9 ± 7.7 |
| cubic cm | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| Left Ventricular End-diastolic Size | 203 ± 39.9 | 236.6 ± 27.1 | 236.5 ± 54.6 |
Collected over Adverse event data was collected over 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VVI-40 | — | 0/11 (0%) | 0/11 (0%) |
| RV DDD-40 | — | 0/13 (0%) | 0/13 (0%) |
| Bi-V DDD-40 | — | 3/12 (25%) | 0/12 (0%) |
| Event | VVI-40 | RV DDD-40 | Bi-V DDD-40 |
|---|---|---|---|
| Heart Failure Exacerbation, Heart TransplantCardiac disorders | 0/11 | 0/13 | 2/12 |
| DeathCardiac disorders | 0/11 | 0/13 | 1/12 |
| DeathInfections and infestations | 0/11 | 0/13 | 0/12 |
| Age, Categorical(participants) | VVI-40 to RV DDD-40 to Bi-V DDD-40 | VVI-40 to Bi-V DDD-40 to RV DDD-40 | Bi-V DDD-40 to VVI-40 to RV DDD-40 | Bi-V DDD-40 to RV DDD-40 to VVI-40 | RV DDD-40 to VVI-40 to Bi-V DDD-40 | RV DDD-40 to Bi-V DDD-40 to VVI-40 | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | — | — | 0 | 0 |
| Between 18 and 65 years | 0 | 1 | 0 | — | — | 2 | 3 |
| >=65 years | 2 | 3 | 5 | — | — | 3 | 13 |
| Gender(participants) | VVI-40 to RV DDD-40 to Bi-V DDD-40 | VVI-40 to Bi-V DDD-40 to RV DDD-40 | Bi-V DDD-40 to VVI-40 to RV DDD-40 | Bi-V DDD-40 to RV DDD-40 to VVI-40 | RV DDD-40 to VVI-40 to Bi-V DDD-40 | RV DDD-40 to Bi-V DDD-40 to VVI-40 | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | — | — | 0 | 0 |
| Male | 2 | 4 | 5 | — | — | 5 | 16 |
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Duke University