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Multi Point Pacing vs. Conventional STUDY PROTOCOL (CRT-MPP)

C

CMC Ambroise Paré

Status

Withdrawn

Conditions

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

Treatments

Device: MPP CRT
Device: conventional CRT

Study type

Interventional

Funder types

Other

Identifiers

NCT04334018
2017/02

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

conventional CRT
Placebo Comparator group
Treatment:
Device: conventional CRT
MPP CRT
Experimental group
Treatment:
Device: MPP CRT

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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