Right Ventricular Resynchronization Therapy (RVRT)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01163422
First received: July 14, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention
Right Ventricular Failure
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Hypertension
Device: Implantation of 3-chamber pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Right Ventricular Resynchronization Therapy for Chronic Thromboembolic Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography [ Time Frame: within 8 months after pacemaker implantation ] [ Designated as safety issue: No ]
  • Increase in cardiac output measured using Doppler echocardiography and scintigraphy [ Time Frame: within 8 months after pacemaker implantation ] [ Designated as safety issue: Yes ]
  • Increase in functional capacity measured with six-minute walking distance [ Time Frame: within 8 months after pacemaker implantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Increase in well-being assessed with questionnaire [ Time Frame: within 8 months after pacemaker implantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163422

Locations
Netherlands
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Medtronic
Investigators
Principal Investigator: Hanno L Tan, MD,PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: Hanno L. Tan, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01163422     History of Changes
Other Study ID Numbers: MEC 09/307
Study First Received: July 14, 2010
Last Updated: July 14, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Right ventricular failure
Pacemaker
Cardiac resynchronization therapy
Pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 18, 2014