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PI left the institution
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This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.
This pilot clinical trial will be a randomized single blinded cross over trial. Each subject will undergo three study stages. Subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. In the second stage, both arms transition to a two months, intervention free, wash out period. Finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV pacing optimization on/off | Experimental | RBBB pacing Arm 1 is RV pacing optimization on/off |
|
| RV pacing optimization off/on | Placebo Comparator | Standard demand pacing Arm 2 is RV pacing optimization off/on |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV DDD(R)-60 with AV optimization | Device | Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG |
| Measure | Description | Time Frame |
|---|---|---|
| Change of LV Ejection Fraction Compared to Baseline | LV Ejection Fraction is defined as [(end diastolic volume minus end systolic volume) / (end diastolic volume] as measured by echocardiography. Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off. Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiographic: QRS Duration | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Baseline to 3 months |
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Inclusion Criteria:
Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months.
LVEF < 35% by trans-thoracic echocardiogram assessment
Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities*
Normal sinus rhythm at enrollment
RBBB with QRS duration >120 msec on 12 lead surface EKG.
PR interval <250 msec on 12 lead surface EKG
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Giudici, MD | University of Iowa | Study Chair |
| Michael C Giudici, MD | University of Iowa | Principal Investigator |
| Shubba D Roy, MD | University of Iowa | Principal Investigator |
| Trisha Elliott, RTR | University of Iowa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RV Pacing Optimization on First, Then Off | Arm 1 is RV pacing optimization on first, then off After baseline measurements, RV DDD(R)-60 with AV optimization (Device is programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG) is turned on for 3 months. After the outcome measurements, RV DDD(R)-60 with AV optimization is turned off for 3 months and final outcome measurements are performed. This is a crossover study. |
| FG001 | RV Pacing Optimization Off First, Then on | Arm 2 is RV pacing optimization off first then on After baseline measurements, RV DDD(R)-60 with AV optimization (Device is programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG) is turned off for 3 months. After the outcome measurements, RV DDD(R)-60 with AV optimization is turned on for 3 months and final outcome measurements are performed. This is a crossover study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RV Pacing Optimization on First, Then Off | RV Pacing Optimization on first, then Off RV DDD(R)-60 with AV optimization: Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change of LV Ejection Fraction Compared to Baseline | LV Ejection Fraction is defined as [(end diastolic volume minus end systolic volume) / (end diastolic volume] as measured by echocardiography. Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off. Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on | Posted | Mean | Standard Deviation | Percent | Baseline to 3 months |
|
Adverse Events and Serious Adverse Events were collected during enrollment period, up to 6 months
Medical record review and directly from participants
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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 | RV Pacing Optimization on | Arm 1 RV pacing optimization on RV DDD(R)-60 with AV optimization: Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barry London | University of Iowa | 319-356-2750 | barry-london@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 24, 2014 | Dec 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 24, 2014 | Dec 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002037 | Bundle-Branch Block |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| RV DDD(R)-60 | Device | AV settings programmed to minimize RV pacing - standard demand pacing programming. |
|
| PI relocated and study terminated |
|
| RV Pacing Optimization Off First, Then on |
RV Pacing Optimization off first, then on RV DDD(R)-60: AV settings programmed to minimize RV pacing - standard demand pacing programming. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Arm 2 is RV pacing optimization off RV DDD(R)-60: AV settings programmed to minimize RV pacing - standard demand pacing programming. |
|
|
| Secondary | Electrocardiographic: QRS Duration | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Posted | Mean | Standard Deviation | Milliseconds | Baseline to 3 months |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | RV Pacing Optimization Off | Arm 2 is RV pacing optimization off RV DDD(R)-60: AV settings programmed to minimize RV pacing - standard demand pacing programming. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |