MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing (MORE CRT MPP)

Abbott

Status

Terminated

Conditions

Heart Failure

Treatments

Device: MPP

Study type

Interventional

Funder types

Industry

Identifiers

NCT02006069

CR-13-006-ID-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,850 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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