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Clinical Trials/NL-OMON32988
NL-OMON32988
Completed
N/A

on-responders of cardiac resynchronization therapy: the effect of left ventricular endocardial pacing and simulated exercise on acute hemodynamic response - non-responders in CRT

Catharina-ziekenhuis0 sites50 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
heart failure NYHA class III or IV
Sponsor
Catharina-ziekenhuis
Enrollment
50
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

Eligibility Criteria

Inclusion Criteria

  • The Class I ACC/AHA/HRS 2008 recommendations for CRT in patients with severe systolic heart failure are used as inclusion criteria. This means that patients who have a LVEF less than or equal to 35%, a QRS duration greater than or equal to 0\.12 seconds with sinus rhythm and NYHA functional class III or ambulatory class IV heart failure symptoms despite optimal recommended medical therapy will be included. Optimal recommended medical therapy is defined as the use of angiotensin\-converting\-enzyme inhibitors or angiotensin\-II\-receptor blockers and beta\-blockers (unless they are not tolerated or contra\-indicated). Although a Class IIa recommendation, patients with atrial fibrillation will also be included.

Exclusion Criteria

  • In case of following criteria patient will be excluded from our study: episode of acute heart failure within 3 months prior to inclusion, change in dosage of beta\-blocker, angiotensin\-converting enzyme inhibitor or angiotensin\-II receptor blocker within 3 months prior to inclusion; unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery within 3 months prior to inclusion; chronic atrial arrhythmias other than atrial fibrillation; any mechanical or biological valve prosthesis, atrial septal defect, right\-to\-left shunt; severe pulmonary hypertension, uncontrolled arterial hypertension; known allergy to sulphur hexafluoride, end\-stage renal or hepatic disease; pregnancy or child\-bearing potential without the use of any birth control measurements; inability to provide a written informed consent; general contra\-indications to magnetic resonance imaging.

Outcomes

Primary Outcomes

Not specified

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