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Right Ventricular Resynchronization Therapy (RVRT)

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ClinicalTrials.gov Identifier: NCT01163422
Recruitment Status : Unknown
Verified December 2009 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Enrolling by invitation
First Posted : July 15, 2010
Last Update Posted : July 15, 2010
Sponsor:
Collaborator:
Medtronic
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief Summary:
The purpose of this study is to determine whether cardiac resynchronization therapy with the use of an implanted electronic pacemaker reduces morbidity associated with chronic thromboembolic pulmonary hypertension

Condition or disease Intervention/treatment Phase
Right Ventricular Failure Chronic Thromboembolic Pulmonary Hypertension Pulmonary Hypertension Device: Implantation of 3-chamber pacemaker Not Applicable

Detailed Description:

Rationale: The clinical severity of right ventricular disease is largely determined by right-to-left ventricular dyssynchrony, i.e., delay of electrical activity between the right and left ventricles. Moreover, in patients with chronic thromboembolic pulmonary hypertension (CTEPH), we found that acute correction of this dyssynchrony by temporary pacing (prior to pulmonary endarterectomy, presently the therapy of choice for CTEPH) results in significant improvement in cardiac output. In this study, we aim to establish whether chronic pacing with the use of implanted pacemakers confers long-lasting improvements in cardiac output and functional class.

Objective: To study whether chronic pacing with implanted pacemakers confers long-lasting improvements in cardiac output and functional class in severely symptomatic CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.

Study design: Chronic intervention study, double-blinded, randomized, cross-over.

Study population: Adult CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.

Intervention (if applicable): chronic right ventricular resynchronization therapy (RVRT), i.e., chronic right atrial, right ventricular, and left ventricular pacing with the use of implanted pacemakers.

Main study parameters/endpoints: (Duration of) improvements (in l/min) in cardiac output as measured using Doppler echocardiography, and functional class as measured using 6-minute walking distance (6-MWD), right and left ventricular dimensions and ejection fractions (99mTechnetium scintigraphy), biomarkers for heart failure (serum NT-proBNP levels), and quality of life (SF-36) questionnaire.

Design: Randomized, double-blind, cross-over study with 2 arms of 10 patients each (arms 1 and 2). In arm 1, RVRT is switched on immediately after pacemaker implant, is switched of in week 5, and switched on at the start of week 6 until study end (32 weeks). In arm 2, RVRT is switched at the start of week 5 after pacemaker implant until study end (32 weeks). At various follow-up visits at weeks 1, 4, 5, 6, 8, 12, 16, the main study parameters/endpoints (see previous paragraph) will be assessed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Right Ventricular Resynchronization Therapy for Chronic Thromboembolic Pulmonary Hypertension
Study Start Date : July 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Immediate RVRT
RVRT switched on immediately after pacemaker implant
 Device: Implantation of 3-chamber pacemaker
Implantation of pacemaker with leads in right atrium, right ventricle, and coronary sinus (left ventricle) with the aim of providing right ventricular resynchronization therapy (RVRT); this is accomplished by pacing the right ventricle ahead of the left ventricle, e.g., by setting (shortening) the A-V delay between right atrium and right ventricle to an optimal level.
Other Name: Medtronic CRT pacemaker systems will be implanted
Placebo Comparator: Delayed RVRT
RVRT switched on 4 weeks after pacemaker implant
 Device: Implantation of 3-chamber pacemaker
Implantation of pacemaker with leads in right atrium, right ventricle, and coronary sinus (left ventricle) with the aim of providing right ventricular resynchronization therapy (RVRT); this is accomplished by pacing the right ventricle ahead of the left ventricle, e.g., by setting (shortening) the A-V delay between right atrium and right ventricle to an optimal level.
Other Name: Medtronic CRT pacemaker systems will be implanted


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography [ Time Frame: within 8 months after pacemaker implantation ]
  2. Increase in cardiac output measured using Doppler echocardiography and scintigraphy [ Time Frame: within 8 months after pacemaker implantation ]
  3. Increase in functional capacity measured with six-minute walking distance [ Time Frame: within 8 months after pacemaker implantation ]

Secondary Outcome Measures :
  1. Increase in well-being assessed with questionnaire [ Time Frame: within 8 months after pacemaker implantation ]

Eligibility Criteria
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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:

Adult patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are ineligible for pulmonary endarterectomy, and those in whom pulmonary endarterectomy has failed

Exclusion Criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163422


Locations
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Netherlands
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Medtronic
Investigators
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Principal Investigator: Hanno L Tan, MD,PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: Hanno L. Tan, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01163422    
Other Study ID Numbers: MEC 09/307
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: December 2009
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Right ventricular failure
Pacemaker
Cardiac resynchronization therapy
Pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases