Heart Failure Clinical Trial
— SPARKOfficial title:
Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)
Verified date | May 2024 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | February 11, 2020 |
Est. primary completion date | February 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Barry London |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 |
Baseline to 3 months | |
Secondary | 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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