MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT02006069
• Date of registration: 23/09/2013
• Prospective Registration: Yes
• Primary sponsor: Abbott Medical Devices
• Public title: MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing MORE-CRT MPP
• Scientific title: MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
• Date of first enrolment: December 2013
• Target sample size: 5850
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02006069
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Australia, Austria, Belgium, Canada, China, Colombia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Republic of, Lebanon, Malaysia, Malta, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Christophe Leclercq
• Affiliation: Centre Cardio-Pneumologique, CHU Pontchaillou

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: MPP

Primary Outcome(s)

CRT Response [Time Frame: Response to CRT after 6 months of MPP]

Secondary Outcome(s)

Reduction of LVESV in acute phase [Time Frame: Baseline vs 6 Months]

NYHA Class changes [Time Frame: Baseline vs 12 Months]

Patient's QoL score changes (MLWHF, EQ-5D) [Time Frame: Baseline vs 12 Months]

Clinical Composite Score evaluation [Time Frame: Baseline vs 12 Months]

6MWT changes [Time Frame: Baseline vs 12 Months]

Reverse LV remodeling [Time Frame: Baseline vs 12 Months]

Secondary ID(s)

CR-13-006-ID-HF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors