Ischemic or Non-ischemic Cardiomyopathy Clinical Trial
— ENHANCE CRTOfficial title:
Cardiac Resynchronization Therapy (CRT) Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.
| NCT number | NCT01983293 |
| Other study ID # | 60037834 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2013 |
| Est. completion date | January 2018 |
| Verified date | February 2019 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
| Status | Completed |
| Enrollment | 248 |
| Est. completion date | January 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration = 120ms) - Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines: - Left ventricular ejection fraction (LVEF) = 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-LBBB pattern with QRS duration = 120 ms, and NYHA) class III/ambulatory class IV on guideline directed medical therapy - Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing - Are 18 years or older, or of legal age to give informed consent specific to state and local law - Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: - Irreversible occlusion of venous access that will prevent placement of the CRT system either through the right or left upper extremity venous system - Undergoing left ventricular lead placement via a surgical or epicardial approach - Cardiomyopathy due solely to valvular disease that is not repaired/replaced - Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by St. Jude Medical, during the course of this clinical study - LBBB: QRS width = 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6 - Incomplete right bundle branch block - intraventricular conduction delay with a QRS duration between 110 and 119ms - Persistent or permanent atrial fibrillation - Pacemaker dependent - Patients who are being upgraded primarily due to right ventricular pacing - Women who are pregnant or who plan to become pregnant during the clinical trial - Life expectancy < 1 year |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University Hospital | Atlanta | Georgia |
| United States | Piedmont Heart Institute | Atlanta | Georgia |
| United States | Johns Hopkins University Hospital | Baltimore | Maryland |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | The Ohio State University | Columbus | Ohio |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | St. John Hospital and Medical Center | Detroit | Michigan |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Sutherland Cardiology Clinic | Germantown | Tennessee |
| United States | Glendale Adventist Medical Center | Glendale | California |
| United States | Baker-Gilmour Cardiovascular Institute | Jacksonville | Florida |
| United States | Cardiovascular Associates, PC | Kingsport | Tennessee |
| United States | Central Baptist Hospital | Lexington | Kentucky |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Bryan LGH Heart Institute | Lincoln | Nebraska |
| United States | USC University Hospital | Los Angeles | California |
| United States | Lynchburg General Hospital | Lynchburg | Virginia |
| United States | Northshore University Hospital | Manhasset | New York |
| United States | Baptist Memorial Hospital | Memphis | Tennessee |
| United States | Cardiovascular Associates of Virginia | Midlothian | Virginia |
| United States | Mission Hospital | Mission Viejo | California |
| United States | McLaren Macomb | Mount Clemens | Michigan |
| United States | Oschner Medical Center | New Orleans | Louisiana |
| United States | Baylor Regional Center at Plano | Plano | Texas |
| United States | Atlanta Heart Associates - Riverdale | Riverdale | Georgia |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | United Hospital | Saint Paul | Minnesota |
| United States | Northside Hospital | Saint Petersburg | Florida |
| United States | St. Joseph's Medical Center | Stockton | California |
| United States | Stony Brook University Medical Center | Stony Brook | New York |
| United States | North Mississippi Medical Center | Tupelo | Mississippi |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States,
Singh JP, Berger RD, Doshi RN, Lloyd M, Moore D, Daoud EG; ENHANCE CRT Study Group. Rationale and design for ENHANCE CRT: QLV implant strategy for non-left bundle branch block patients. ESC Heart Fail. 2018 Dec;5(6):1184-1190. doi: 10.1002/ehf2.12340. Epub 2018 Sep 27. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With Improved Clinical Composite Score | Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. | 12 months |