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Multipolar CRT-d and Diabetes

NCT03095196 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2017-04-25

No results posted yet for this study

Summary

Background: Type 2 Diabetes Mellitus (T2DM) is a multi factorial disease, affecting clinical outcomes in failing heart (HF) patients treated by Cardiac Resynchronization Therapy with a defibrillator (CRT-d).

Methods: One hundred and ninety five T2DM patients will receive a CRT-d treatment. Randomly the study population will receive a CRT-d via multipolar left ventricle (LV) lead pacing (n 99 as Multipolar group), v/s a CRT-d via bipolar LV pacing (n 96, as Bipolar group). These patients will be followed by clinical, and instrumental assessment, and telemetric device control at follow up. Study design will be to evaluate, in failing heart T2DM patients, cardiac deaths, all cause deaths, arrhythmic events, CRT-d responders rate, hospitalizations for HF worsening, phrenic nerve stimulation (PNS), and LV catheter dislodgment events (and re-intervention for LV catheter re-positioning), comparing multipolar CRT-d v/s bipolar CRT-d group of patients at follow up.

Conditions

Interventions

DEVICE

Multipolar CRT-d, plus conventional drug therapy for HF.

A random CRT-d implant performed via multipolar left ventricle lead, in failing heart patients treated by maximal drug therapy.

DEVICE

Bipolar CRT-d, plus conventional drug therapy for HF.

A random CRT-d implant performed via bipolar left ventricle lead (group B), in failing heart patients treated by maximal drug therapy.

DRUG

HF drugs

full medical therapy to treat HF symptoms and its progression.

Sponsors & Collaborators

  • Celestino Sardu

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-01
Primary Completion
2014-09-01
Completion
2015-09-01
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095196 on ClinicalTrials.gov