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

Heart Failure Clinical Trial

Official title:

Non-Responders in Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01193712
• Other study ID #: NL26963.060.09
• Status: Withdrawn
• Phase: N/A
• First received: August 25, 2010
• Last updated: February 2, 2015
• Start date: August 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2015
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	improvement in NYHA functional class =1		baseline and 3 months	No
Secondary	decrease in MLWHFQ of =9 points		baseline and 3 months	No
Secondary	decrease in LVESV of =15%		baseline and 3 months	No
Secondary	increase in LVEF of =5%		baseline and 3 months	No