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Endocardial Pacing in On-table Non-responders in Cardiac Resynchronization Therapy

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ClinicalTrials.gov Identifier: NCT01193712
Recruitment Status : Withdrawn (too limited number of eligible patients)
First Posted : September 2, 2010
Last Update Posted : February 3, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure Procedure: temporary left ventricular endocardial pacing

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Responders in Cardiac Resynchronization Therapy
Study Start Date : August 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012
Arms and Interventions

Arm Intervention/treatment
on-table non-responder
patients who do not show an improvement of more than or equal to 15% in LV dP/dtmax measured immediately after implantation of a cardiac resynchronization therapy device
Procedure: temporary left ventricular endocardial pacing
a temporary pacemaker lead will be introduced through the aortic valve to evaluate the effect of left ventricular endocardial pacing. Four different pacing sites (basal and apical septal, basal and apical lateral) will be investigated with measurement of LV dP/dtmax. Afterwards, the endocardial pacing lead will be removed.
No Intervention: on-table responders
patients who do show an improvement of more than or equal to 15% in LV dP/dtmax measured immediately after implantation of a cardiac resynchronization therapy device

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. improvement in NYHA functional class ≥1 [ Time Frame: baseline and 3 months ]
  2. decrease in MLWHFQ of ≥9 points [ Time Frame: baseline and 3 months ]
  3. decrease in LVESV of ≥15% [ Time Frame: baseline and 3 months ]
  4. increase in LVEF of ≥5% [ Time Frame: baseline and 3 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥18y
  2. LVEF ≤35%
  3. QRS-duration ≥0.12 seconds
  4. 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
  5. sinus rhythm or atrial fibrillation

Exclusion Criteria:

  1. episode of acute heart failure ≤3 months
  2. change in dosage of beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin-II receptor blockers ≤3 months
  3. unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery ≤3 months
  4. chronic atrial arrhythmias other than atrial fibrillation
  5. any mechanical or biological valve prosthesis
  6. atrial septal defect
  7. right-to-left shunt
  8. severe pulmonary hypertension (systolic pulmonary artery pressure >90 mmHg)
  9. uncontrolled arterial hypertension
  10. known allergy to sulphur hexafluoride
  11. end-stage renal or hepatic disease
  12. inability to provide written informed consent
  13. pregnancy or childbearing potential without use of birth-control measurements
  14. general contra-indications to magnetic resonance imaging
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193712

Catharina Ziekenhuis
Eindhoven, Netherlands
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Principal Investigator: Patrick Houthuizen, MD Catharina Ziekenhuis Eindhoven
More Information

Responsible Party: Patrick Houthuizen, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01193712     History of Changes
Other Study ID Numbers: NL26963.060.09
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by Patrick Houthuizen, Catharina Ziekenhuis Eindhoven:
Electrophysiologic Techniques, Cardiac

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases