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

Primary Purpose

Heart Failure

Status

Withdrawn

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

temporary left ventricular endocardial pacing

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Electrophysiologic Techniques, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18y
LVEF ≤35%
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

Sites / Locations

Catharina Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

on-table non-responder

on-table responders

Arm Description

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

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

Outcomes

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.

Secondary Outcome Measures

improvement in NYHA functional class ≥1

decrease in MLWHFQ of ≥9 points

decrease in LVESV of ≥15%

increase in LVEF of ≥5%

Full Information

NCT ID

NCT01193712

First Posted

August 25, 2010

Last Updated

February 2, 2015

Sponsor

Catharina Ziekenhuis Eindhoven

1. Study Identification

Unique Protocol Identification Number

NCT01193712

Brief Title

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

Official Title

Non-Responders in Cardiac Resynchronization Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Withdrawn

Why Stopped

too limited number of eligible patients

Study Start Date

August 2010 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catharina Ziekenhuis Eindhoven

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Electrophysiologic Techniques, Cardiac

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

on-table non-responder

Arm Type

Other

Arm Description

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

Arm Title

on-table responders

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

temporary left ventricular endocardial pacing

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

improvement in NYHA functional class ≥1

Time Frame

baseline and 3 months

Title

decrease in MLWHFQ of ≥9 points

Time Frame

baseline and 3 months

Title

decrease in LVESV of ≥15%

Time Frame

baseline and 3 months

Title

increase in LVEF of ≥5%

Time Frame

baseline and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18y LVEF ≤35% 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Houthuizen, MD

Organizational Affiliation

Catharina Ziekenhuis Eindhoven

Official's Role

Principal Investigator

Facility Information:

Facility Name

Catharina Ziekenhuis

City

Eindhoven

Country

Netherlands

12. IPD Sharing Statement

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

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