MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

Not Applicable

Terminated

Conditions: Heart Failure

Registration Number: NCT02006069

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Detailed Description: This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5850

Inclusion Criteria

Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
Must be willing and able to comply with study requirements
Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria

Already had a CRT device implanted
Myocardial Infarction, unstable angina within 40 days prior the enrollment
Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
Primary valvular disease
Atrial Fibrillation:
- Persistent AF at the time of enrollment
- Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
- History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
Unable to comply with the follow up schedule
Less than 18 years of age
Pregnant or are planning to become pregnant during the duration of the investigation
Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
Undergone a cardiac transplantation
Life expectancy < 12 months
Currently participating in any other clinical investigation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Non-responder Patients Who Converted to Responders	Non-responder to responder conversion rate between randomization at 6 months and 12 months	The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.

Secondary Outcome Measures

Name	Time	Method
Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase	Baseline vs 6 Months	Reduction of LVESV between baseline and 6 Months visit
Clinical Composite Score Evaluation	Baseline vs 12 Months	Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below, * Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation * Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation * Unchanged: the patient was neither improved nor worsened
Reverse Left Ventricular (LV) Remodeling	Baseline vs 12 Months	Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
NYHA Class Changes	Baseline vs 12 Months	Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
6MWT Changes	Baseline vs 12 Months	Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
Patient's QoL Score Changes (MLWHF)	Baseline vs 12 Months	Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).

Trial Locations

Locations (206): Heart Center Research, LLC.
🇺🇸
Huntsville, Alabama, United States
Cardiovascular Associates of Mesa
🇺🇸
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group
🇺🇸
Phoenix, Arizona, United States
Comprehensive Cardiovascular
🇺🇸
Bakersfield, California, United States
Glendale Adventist Medical Center
🇺🇸
Glendale, California, United States
Scripps Health
🇺🇸
La Jolla, California, United States
Eisenhower Medical Center
🇺🇸
Rancho Mirage, California, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸
Reseda, California, United States
San Diego Cardiac Center
🇺🇸
San Diego, California, United States
Colorado Heart & Vascular, P.C.
🇺🇸
Lakewood, Colorado, United States
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Heart Center Research, LLC.
🇺🇸Huntsville, Alabama, United States