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Clinical Trials/NL-OMON49313
NL-OMON49313
Completed
N/A

Advanced Image Supported Left Ventricular Lead Placement in Cardiac Resynchronization Therapy (ADVISE-CRT II trial) - ADVISE-CRT II trial

niversitair Medisch Centrum Utrecht0 sites30 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiomyopathy
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
30
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • An indication for cardiac resynchronization therapy according to the current
  • international evidence based guidelines for CRT (the 2013 European Society of
  • Cardiology Guidelines for cardiac pacing and cardiac resynchronization therapy)
  • \- Chronic heart failure;
  • \- New York Heart Association functional class II, III, IV (ambulatory);
  • \- QRS duration \*120ms;
  • \- Optimal pharmacological therapy;
  • \- Left ventricular ejection fraction \*35%;

Exclusion Criteria

  • \- Contraindications for implantation of a CRT device;
  • \- Age \<18 years or incapacitated adult;
  • \- Pregnancy; if there is anamnestic doubt regarding postmenopausal state (\<1
  • year since last menstruation), a urine hCG test (Alere) will be performed.
  • \- Subjects with impaired renal function (severe renal insufficiency, GFR \< 30
  • ml/min/1\.73m2\);
  • \- Atrial fibrillation or atrial fibrillation during MRI
  • \- Lactation;
  • \- Documented allergic reaction to gadolinium;
  • \- Documented allergic reaction to contrast agent;

Outcomes

Primary Outcomes

Not specified

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