Heart Failure, Systolic Clinical Trial
Official title:
Real-Time Intracardiac Impedograms of Left Ventricular Leads to Locate Sites of Latest Mechanical Delay in Cardiac Resynchronization Therapy
Verified date | January 2015 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with NYHA class III or IV heart failure - LVEF = 30% - QRS duration = 120 ms Exclusion Criteria: - Not a candidate for CRT implantation |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map. | Parameter will be recorded for at least 10 consecutive heartbeats during sinus and RV paced rhythm Ts = The average time from the sensed RV IEGM to the peak of the LV impedance curve |
Acute intraoperative measurement | No |
Secondary | Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map. | Ts: The average time from the sensed RV IEGM to the peak of the LV impedance curve. Tp: The average time from the paced RV IEGM to the peak of the LV impedance curve. Td: The difference between Ts and Tp (Tp - Ts). |
Acute intraoperative measurement | No |
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