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Clinical Trials/NL-OMON32443
NL-OMON32443
Completed
Phase 3

Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation - EchoCRT

BIOTRONIK Inc. - clinical study department0 sites20 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
BIOTRONIK Inc. - clinical study department
Enrollment
20
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
BIOTRONIK Inc. - clinical study department

Eligibility Criteria

Inclusion Criteria

  • •indication for ICD
  • •systolic heart failure: LVEF \< 35% and LVEDD \> 55 mm
  • •NYHA III\-IV under optimal medical therapy
  • •QRS \< 130 ms
  • •ventricular dyssynchrony measured by Echo \+ confirmed by Echo Core Lab
  • •18 years of age or older

Exclusion Criteria

  • •Contraindication(s) to an ICD.
  • •Already implanted with a pacemaker or an ICD
  • •Bradycardia pacing indication
  • •Pregnant, lactating or planning to become pregnant females.
  • •CABG, PTCA, or MI within the past 3 months prior to enrollment or CABG or PTCA intervention planned in the next 3 months.
  • •Irreversible brain damage from preexisting cerebral disease.
  • •Reversible non\-ischemic cardiomyopathy such as acute viral myocarditis.
  • •Permanent 2º or 3º heart block.
  • •Chagas disease.
  • •Persistent, permanent, or paroxysmal atrial fibrillation within 1 month prior to enrollment.

Outcomes

Primary Outcomes

Not specified

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