Status:
WITHDRAWN
Endocardial Pacing in On-table Non-responders in Cardiac Resynchronization Therapy
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether left ventricular endocardial pacing exhibits a greater acute hemodynamic response during biventricular pacing in patients who do not show this respons...
Detailed Description
Cardiac resynchronisation therapy (CRT) with biventricular pacemakers and implantable cardiac defibrillators (ICD) has proven to be a valuable therapy in selected patients with systolic heart failure,...
Eligibility Criteria
Inclusion
- Age ≥18y
- LVEF ≤35%
- QRS-duration ≥0.12 seconds
- NYHA functional class III or IV despite optimal medical therapy defined as use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor blocker and beta-blockers unless they are not tolerated or contra-indicated
- sinus rhythm or atrial fibrillation
Exclusion
- episode of acute heart failure ≤3 months
- change in dosage of beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin-II receptor blockers ≤3 months
- unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery ≤3 months
- chronic atrial arrhythmias other than atrial fibrillation
- any mechanical or biological valve prosthesis
- atrial septal defect
- right-to-left shunt
- severe pulmonary hypertension (systolic pulmonary artery pressure \>90 mmHg)
- uncontrolled arterial hypertension
- known allergy to sulphur hexafluoride
- end-stage renal or hepatic disease
- inability to provide written informed consent
- pregnancy or childbearing potential without use of birth-control measurements
- general contra-indications to magnetic resonance imaging
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01193712
Start Date
August 1 2010
End Date
April 1 2012
Last Update
February 3 2015
Active Locations (1)
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1
Catharina Ziekenhuis
Eindhoven, Netherlands