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

NCT ID: NCT01193712

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-04-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

temporary left ventricular endocardial pacing

Intervention Type: PROCEDURE

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Patrick Houthuizen

Patrick Houthuizen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Houthuizen, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Ziekenhuis

Eindhoven, , Netherlands

Countries

Netherlands

Other Identifiers

NL26963.060.09

Identifier Type: -

Identifier Source: org_study_id