NCT01163422

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 15, 2010

Status Verified

December 1, 2009

Enrollment Period

2 years

First QC Date

July 14, 2010

Last Update Submit

July 14, 2010

Conditions

Right Ventricular FailureChronic Thromboembolic Pulmonary HypertensionPulmonary Hypertension

Keywords

Right ventricular failurePacemakerCardiac resynchronization therapyPulmonary hypertension

Outcome Measures

Primary Outcomes (3)

  • Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography

    within 8 months after pacemaker implantation

  • Increase in cardiac output measured using Doppler echocardiography and scintigraphy

    within 8 months after pacemaker implantation

  • Increase in functional capacity measured with six-minute walking distance

    within 8 months after pacemaker implantation

Secondary Outcomes (1)

  • Increase in well-being assessed with questionnaire

    within 8 months after pacemaker implantation

Study Arms (2)

Immediate RVRT

ACTIVE COMPARATOR

RVRT switched on immediately after pacemaker implant

Device: Implantation of 3-chamber pacemaker

Delayed RVRT

PLACEBO COMPARATOR

RVRT switched on 4 weeks after pacemaker implant

Device: Implantation of 3-chamber pacemaker

Interventions

Implantation of 3-chamber pacemakerDEVICE

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.

Also known as: Medtronic CRT pacemaker systems will be implanted
Delayed RVRTImmediate RVRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center, University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Heart FailureHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Study Officials

  • Hanno L Tan, MD,PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 15, 2010

Record last verified: 2009-12

Locations

NL(1)