Non-Responders in Cardiac Resynchronization Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- change in acute hemodynamic response to CRT defined as an increase in LV dP/dtmax of ≥10% during left endocardial pacing compared to left epicardial pacing.
Study Overview
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 response to standard cardiac resynchronization therapy.
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, ameliorating both morbidity and mortality. However, with current selection criteria and implant technique, about 20 to 30 % of patients remain non-responders. Non-responders might be due to failing selection criteria or methodology in casu echocardiography. However, an important number of non-responders may result of sub-optimal positioning of the left ventricular lead, remote from the site of delayed activation. Endocardial left ventricular stimulation may ameliorate the shortcomings of epicardial stimulation. The advantage of an endocardial approach is the absence of phrenic nerve stimulation which regularly complicates epicardial pacing, a more predictable pacing threshold and much less restriction to position the lead in the area of interest. Transseptal left ventricular endocardial pacing has already been used in patients in whom standard epicardial pacing was not applicable.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
change in acute hemodynamic response to CRT defined as an increase in LV dP/dtmax of ≥10% during left endocardial pacing compared to left epicardial pacing.
Time Frame: baseline and 3 months
Secondary Outcomes
- improvement in NYHA functional class ≥1(baseline and 3 months)
- decrease in MLWHFQ of ≥9 points(baseline and 3 months)
- decrease in LVESV of ≥15%(baseline and 3 months)
- increase in LVEF of ≥5%(baseline and 3 months)
Investigators
Patrick Houthuizen
Patrick Houthuizen
Catharina Ziekenhuis Eindhoven