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

NCT01193712 | Withdrawn

• 1 other identifier: NL26963.060.09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Electrophysiologic Techniques, Cardiac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

on-table non-responder

OTHER

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

on-table responders

NO INTERVENTION

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

Interventions

temporary left ventricular endocardial pacing 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 non-responder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Patrick Houthuizen, MD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patrick Houthuizen

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: September 2, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

NL (1)