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Clinical Trials/NL-OMON29327
NL-OMON29327
Recruiting
N/A

Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

niversity Medical Center Utrecht0 sites130 target enrollmentTBD
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ConditionsChronic heart failure with a reduced ejection fraction and dyssynchrony

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic heart failure with a reduced ejection fraction and dyssynchrony
Sponsor
niversity Medical Center Utrecht
Enrollment
130
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

For previous work, please see Salden OAE et al. Multimodality imaging for real-time image-guided left ventricular lead placement during cardiac resynchronization therapy implantations. 2019. Int J Cardiovasc Imaging. 2019 Jul;35(7):1327-1337.

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

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Heart failure with LV ejection fraction \= 35%;
  • •\- New York Heart Association class II, III, or IV (ambulatory);
  • •\- Optimal medical treatment that is tolerable;
  • •\- Left bundle branch block (LBBB) and QRS \= 130 ms, OR non\-LBBB and QRS \= 150 ms.

Exclusion Criteria

  • •Contraindications for implantation of a CRT device;
  • •\- Age \<18 years or incapacitated adult;
  • •\- Pregnancy or lactation
  • •\- Subjects with impaired renal function (severe renal insufficiency, GFR \< 30 ml/min/1\.73m2\);
  • •\- Atrial fibrillation or atrial fibrillation during MRI
  • •\- Documented allergic reaction to gadolinium;
  • •\- Impossibility to undergo an MRI scan
  • •\- Participation in another clinical study that prohibits any procedures other than standard.

Outcomes

Primary Outcomes

Not specified

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