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A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.

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ClinicalTrials.gov Identifier: NCT02247817
Recruitment Status : Unknown
Verified September 2014 by Jasper J. Schouwenburg, University Medical Center Groningen.
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Jasper J. Schouwenburg, University Medical Center Groningen

Brief Summary:
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.

Condition or disease Intervention/treatment Phase
Heart Failure With Intraventricular Conduction Delay Device: Hybrid CRT-D/P implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2014
Estimated Primary Completion Date : December 2014

Arm Intervention/treatment
Experimental: HYBRID
Hybrid transvenous/epicardial implantation of a CRT-(D) device.
Device: Hybrid CRT-D/P implantation



Primary Outcome Measures :
  1. Number of procedure related serious adverse events [ Time Frame: 30 days after implantation of device ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • NYHA class II-III.
  • Left ventricular ejection fraction ≤ 35%.
  • QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology.
  • No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
  • On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists.
  • Age ≥ 18 years.
  • Signed informed consent.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • Coronary ischemia or a recent myocardial infarction (< 6 months).
  • Allready a CRT-device implanted.
  • Venous thrombosis without options to reach the right heart.
  • Presence of any other condition than HF with a life expectancy of < 1 year.
  • History of intrathoracic surgery.
  • Presence or suspected presence of a noncompliant left lung.
  • Participation in another intervention trial.
  • Unable to understand Dutch language.
  • Pregnant women.

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Responsible Party: Jasper J. Schouwenburg, Drs., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02247817     History of Changes
Other Study ID Numbers: METc 2013/387
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases