NCT01821651

Brief Summary

Objectives: Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite. Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety). This pilot study aims at observing these aims on a small patient population and a control group. Number of Subjects: 140 patients total in 6 groups:

  • MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
  • MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
  • TAVI with HeartNavigator lead in (10)
  • TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).

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
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

December 10, 2012

Last Update Submit

June 18, 2013

Conditions

Heart Valve Diseases

Keywords

TAVIMitraClipimage modalityechocardiographyangiography

Outcome Measures

Primary Outcomes (1)

  • Radiation Dose (mSv) administered to each patient

    At the end of the procedure the recorded radiation-dose is assessed.

    Day of intervention (day 1)

Secondary Outcomes (5)

  • Duration of the intervention (minutes)

    Day of intervention (day 1)

  • Contrast agent dose (ml)

    Day of intervention (day 1)

  • Increased quality of care (EchoNav group)

    Discharge: 1 to 5 days after intervention

  • Degree of Mitral Regurgitation (EchoNav group)

    Discharge: 1 to 5 days after intervention

  • Postinterventional transvalvular gradient

    Up to 7 days after intervention

Study Arms (4)

HeartNavigator

EXPERIMENTAL

Group with HeartNavigator-Software

Device: HeartNavigator

Control

ACTIVE COMPARATOR

Control-group without HeartNavigator-Software

Other: Control-group HN

EchoNav

EXPERIMENTAL

Group with EchoNav-Software

Device: EchoNav

Conrol

ACTIVE COMPARATOR

Control-group without EchoNav-Software

Other: Control-Group EN

Interventions

HeartNavigatorDEVICE

Procedure with software

Also known as: HeartNavigator, procedure with software
HeartNavigator
EchoNavDEVICE

Procedure with software

Also known as: EchoNav, procedure with software
EchoNav
Control-Group ENOTHER

Procedure without software

Also known as: Compare to EchoNav-group
Conrol
Control-group HNOTHER

Procedure without software

Also known as: Compare to HeartNavigator-group
Control

Eligibility Criteria

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

You may qualify if:

  • Male and female patients over 18 years of age.
  • Ability and willingness to give informed consent.
  • Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.
  • Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).

You may not qualify if:

  • Contraindications on ethical grounds,
  • Women who are pregnant or breast feeding,
  • Emergency cases,
  • Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,
  • Known renal insufficiency (GFR \< 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),
  • Contraindications for transesophageal Echo (EchoNav patients only, TAVI is possible without TEE and TEE is not needed for the HeartNavigator),
  • Known or suspected drug or alcohol abuse,
  • Enrollment into a clinical trial within last 4 weeks if overlapping enrolment is not explicitly approved by ethics committee for the two trials,
  • Patient is unable or unwilling to cooperate with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Cardiovascular Surgery

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Volkmar Falk, Prof MD

    University Hospital Zurich, Division of Cardiovascular Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Sündermann, MD

CONTACT

simon.suendermann@usz.ch

Volkmar Falk, Prof MD

CONTACT

volkmar.falk@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

April 1, 2013

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

CH(1)