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Multi Point Pacing vs. Conventional STUDY PROTOCOL

Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04334018
Acronym
CRT-MPP
Enrollment
0
Registered
2020-04-03
Start date
2018-03-01
Completion date
2023-03-01
Last updated
2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy

Brief summary

The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy

Interventions

Conventional CRT or biventricular pacing resynchronizes left ventricular contraction by pacing the right and left ventricles (LV) simultaneously

DEVICEMPP CRT

CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months

Exclusion criteria

* \< 18 years and younger * Pregnant or breastfeeding patients * Non-LBBB patients (RBBB, intra-ventricular delay) * Non-ambulatory NYHA class IV effort tolerance * Myocardial infarction within 40 days before enrolment * Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months * Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery) * Patients with life expectancy of less than 12 months due to other medical conditions * Patients who are involved in another investigational study (device or medical)

Design outcomes

Primary

MeasureTime frameDescription
Outcome 112 monthsTo evaluate the clinical improvement of CRT MPP as compared to conventional CRT in Heart Failure patients with indication for CRT using automated intra-cardiac EGMs analysis (QuickOpt™) for device optimization, in a large multicentre international study.

Countries

France, Monaco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026