Heart Failure, Right Bundle-Branch Block
Conditions
Keywords
Cardiac Resynchronization therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICERV 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
DEVICERV DDD(R)-60
AV settings programmed to minimize RV pacing - standard demand pacing programming.
Sponsors
Barry London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Subjects with biventricular pacemaker/ICD will be eligible for enrollment if their LV lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the LV pacing therapy for any reason per primary cardiologist discretion)
Exclusion criteria
* Age younger than 18 years old * Pregnancy * Acute Myocardial infarction within 6 months of entry into the study * Inotrope dependent heart failure condition * Left ventricular assist device or heart transplantation * Any other known conditions other than heart failure that could limit survival to \< 6 months. * Atrial fibrillation or flutter burden \>10% of the time within the last 6 months * Atrioventricular node disease that requires ventricular pacemaker support \>10% of the time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of LV Ejection Fraction Compared to Baseline | Baseline to 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiographic: QRS Duration | Baseline to 3 months | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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. | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | PI relocated and study terminated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | RV Pacing Optimization on First, Then Off | RV Pacing Optimization Off First, Then on | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 78 years STANDARD_DEVIATION 9 | 62 years STANDARD_DEVIATION 15 | 70 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RV Pacing Optimization on | Change of LV Ejection Fraction Compared to Baseline | 0 Percent | Standard Deviation 4 |
| RV Pacing Optimization Off | Change of LV Ejection Fraction Compared to Baseline | 4 Percent | Standard Deviation 7 |
Secondary
Electrocardiographic: QRS Duration
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RV Pacing Optimization on | Electrocardiographic: QRS Duration | -36 Milliseconds | Standard Deviation 22 |
| RV Pacing Optimization Off | Electrocardiographic: QRS Duration | 2 Milliseconds | Standard Deviation 9 |