CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT)
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|ClinicalTrials.gov Identifier: NCT01983293|
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : January 1, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-left Bundle Branch Block Ischemic or Non-ischemic Cardiomyopathy||Device: QLV based implant strategy Device: Standard of care implant strategy||Not Applicable|
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients.
In the QLV arm the physician will:
- Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement.
- Measure QLV for each of the four cathodes of the left ventricular lead in each branch.
- Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode.
In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official 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.|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Experimental: QLV based implant strategy
QLV represents the pacing site with the largest amount of dyssynchrony as measured by the left ventricular electrical delay. The QLV based implant strategy finds the left ventricle vein branch and left ventricular lead cathode with the longest QLV measurement and places the lead at this location and programs the device using this lead cathode.
Device: QLV based implant strategy
Placebo Comparator: Standard of care implant strategy
The placement of LV lead will be carried out according to the physician's standard of care implant approach.
Device: Standard of care implant strategy
- Number of Patients With Improved Clinical Composite Score [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983293
Show 32 Study Locations
|Study Chair:||Jagmeet Singh, MD, PhD||Massachusetts General Hospital|