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

Non-Responders in Cardiac Resynchronization Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Patrick Houthuizen, MD, Catharina Ziekenhuis Eindhoven

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: September 1, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Estimate): February 3, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Electrophysiologic Techniques, Cardiac
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NL26963.060.09