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CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01983293
First received: October 31, 2013
Last updated: August 10, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to analyze the effect of left ventricular (LV) lead pacing location in the non-left bundle branch block (NLBBB)heart failure (HF) patient population. The LV 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.

Condition Intervention
Non-left Bundle Branch Block Ischemic or Non-ischemic Cardiomyopathy Other: QLV based implant strategy Other: Standard of care implant strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Improved Clinical Composite Score [ Time Frame: 12 months ]
    Evaluate the Clinical composite score at 12 months in NLBBB patients using a standard of care versus latest electrical delay (QLV) based implant strategy. The Clinical composite score includes 4 components: New York Heart Association (NYHA)class, Patient Global Assessment (PGA), HF events, and cardiovascular death.


Enrollment: 252
Study Start Date: November 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QLV based implant strategy
QLV is the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay. The QLV based implant strategy is choosing the vein branch and the cathode with the longest QLV measurement and programming a vector based on that cathode.
Other: 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
Other: Standard of care implant strategy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have NLBBB 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 (ACCF/AHA/HRS) guidelines:

    • Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-LBBB pattern with QRS duration ≥ 120 ms, and New York Heart Association (NYHA) class III/ambulatory class IV on guideline directed medical therapy (GDMT)
  • Receiving a new cardiac resynchronization therapy (CRT) implant or undergoing an upgrade from an existing implantable cardioverter defibrillator (ICD) or pacemaker implant with no more than 10% right ventricular (RV) 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-ICD 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
  • Left bundle branch block (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 (RBBB)
  • IVCD with a QRS duration between 110 and 119ms
  • Persistent or Permanent atrial fibrillation
  • Pacemaker dependent
  • Patients who are being upgraded primarily due to RV pacing
  • Women who are pregnant or who plan to become pregnant during the clinical trial
  • Life expectancy < 1 year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983293

  Show 32 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Jagmeet Singh, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01983293     History of Changes
Other Study ID Numbers: 60037834
Study First Received: October 31, 2013
Last Updated: August 10, 2017

Keywords provided by St. Jude Medical:
Non-left bundle branch block
QLV
LV lead pacing location
CRT-D

Additional relevant MeSH terms:
Cardiomyopathies
Bundle-Branch Block
Heart Block
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017