NCT02243839

Brief Summary

Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity The best treatment of PVT is controversial, although surgery and thrombolysis options have been available. In this randomized and multicenter study, the investigators compared thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic valve thrombosis.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

1.6 years

First QC Date

September 12, 2014

Last Update Submit

September 16, 2014

Conditions

Obstructive Thrombus

Keywords

Prosthetic valveThrombosisSurgeryThrombolytic therapyTransesophageal echocardiography

Outcome Measures

Primary Outcomes (5)

  • Thrombolytic success

    In the absence of fatal or nonfatal major complications; Obstructive thrombus: Doppler documentation of the resolution of increased gradient and decreased valve area. Clinical improvement in symptoms. Reduction by ≥75% in major diameter or area of the thrombus. Complete success was defined when all 3 criteria were met and partial success was defined as less than 3 Nonobstrucive thrombus: Complete success: ≥75% reduction in thrombus area. Partial success: 50%-75% reduction in thrombus area

    Up to 10 days

  • Non-fatal complications for thrombolytic therapy

    Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion. Nonfatal minor complication: Bleeding without need for transfusion, TIA.

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Successful Surgery

    Successful redo valve surgery in the absence of fatal and non fatal major complications.

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months

  • Complications for surgery

    Non fatal major complications: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, pericardial tamponade, sepsis, pacemaker requirement, mediastinitis, wound infections, acute renal failure Minor complications: bleeding requiring transfusion, plevral effusion, pericardial effusion without tamponade

    Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month

  • In hospital mortality

    All cause in-hospital mortality.

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

Thrombolytic therapy

ACTIVE COMPARATOR

In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra-slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours.

Drug: Thrombolytic Therapy

Surgery

ACTIVE COMPARATOR

In the second arm, redo valve surgery is performed for obstructive valve thrombosis. Intraoperative and postoperative results are recorded

Procedure: Surgery

Interventions

Thrombolytic TherapyDRUG

Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis

Thrombolytic therapy
SurgeryPROCEDURE

Redo valve surgery is performed for obstructive valve thrombosis

Surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructive prosthetic valve thrombosis

You may not qualify if:

  • Non-obstructive prosthetic valve thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosuyolu Kartal Heart Training and Research Hospital

Istanbul, 34844, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Thrombolytic TherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 18, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

TU(1)