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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Catharina Ziekenhuis Eindhoven.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01193712
First received: August 25, 2010
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Heart Failure
 Procedure: temporary left ventricular endocardial pacing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Responders in Cardiac Resynchronization Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement in NYHA functional class ≥1 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • decrease in MLWHFQ of ≥9 points [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • decrease in LVESV of ≥15% [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • increase in LVEF of ≥5% [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193712

Contacts
Contact: Patrick Houthuizen, MD +31 (0)40-2397000 aasphn@cze.nl
Contact: Frank Bracke, MD, PhD +31 (0)40-2397000 carfbe@cze.nl

Locations
Netherlands
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands
Contact: Patrick Houthuizen, MD     +31 (0)40-2397000     aasphn@cze.nl    
Contact: Frank Bracke, MD, PhD     +31 (0)40-2397000     carfbe@cze.nl    
Principal Investigator: Patrick Houthuizen, MD            
Sub-Investigator: Frank Bracke, MD, PhD            
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Patrick Houthuizen, MD Catharina Ziekenhuis Eindhoven
  More Information

No publications provided

Responsible Party: P. Houthuizen MD, Catharina Hospital Eindhoven
ClinicalTrials.gov Identifier: NCT01193712     History of Changes
Other Study ID Numbers: NL26963.060.09
Study First Received: August 25, 2010
Last Updated: June 22, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Electrophysiologic Techniques, Cardiac

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013