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Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY TAVI)

This study is not yet open for participant recruitment.
Verified March 2017 by Groupe Hospitalier Mutualiste de Grenoble
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781896
First Posted: May 25, 2016
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Centre Recherche Cardiovasculaire Alpes
Information provided by (Responsible Party):
Groupe Hospitalier Mutualiste de Grenoble
  Purpose
The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method.

Condition Intervention
Aortic Valve Stenosis Device: pacing catheter Device: valve delivery guidewire

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Mutualiste de Grenoble:

Primary Outcome Measures:
  • Total TAVI procedural duration [ Time Frame: 1 month ]
    Duration of TAVI procedure is calculated from the first puncture to the last sheath removal


Secondary Outcome Measures:
  • Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency) [ Time Frame: 1 month ]
    Stimulation efficiency is defined as a drop in systolic blood pressure reaching at least 60 mmHg during the prolonged stimulation without loss of capture for more than 30s.

  • Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety) [ Time Frame: 1 month ]
    Safety includes success of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades

  • Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness) [ Time Frame: 1 month ]
    Study costs includes direct costs (material used for the rapid pacing) and indirect costs (medical complications)


Estimated Enrollment: 300
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Right ventricular pacing
Rapid pacing during TAVI is provided by a temporary pacing catheter placed in the right ventricle. An additional venous vascular access is required.
Device: pacing catheter
Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the right ventricular pacing arm, rapid pacing is provided by a standard right ventricular pacing catheter.
Other Names:
  • transvenous stimulation electrode
  • pacing lead
  • pacing wire
Experimental: Left ventricular pacing
Rapid pacing during TAVI is provided by the valve delivery guidewire inserted into the left ventricle using two alligator clamps. One clamp is attached directly to the skin at the femoral entry site, the other is attached to the body of the valve delivery guidewire. No additional venous vascular access is required.
Device: valve delivery guidewire
Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the Left ventricular pacing arm, rapid pacing is provided via the valve-delivery guidewire inserted into the left ventricle. The cathode of an external pacemaker is placed on the external end of the guidewire using an alligator clamp. The TAVI catheter provides the necessary insulation. The anode is attached directly to the subcutaneous tissue at the femoral entry site (also using an alligator clamp).

Detailed Description:

Use of temporary pacing via a right ventricular lead in TAVI is still mandatory to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. This requires an additional venous vascular access and a pacing catheter which are both likely to generate complications.

This study compares the standard right ventricular rapid pacing to a new and simplified technique : a left ventricular rapid pacing is provided via the back-up 0.035 " guidewire. The cathode of an external pacemaker is placed on the tip of the 0.035" wire and the anode on a needle inserted into the groin. Insulation is ensured by the balloon or TAVI catheter.

  Eligibility

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is eligible for a TAVI
  • Access considered for aortic valve bioprothesis delivery is transfemoral
  • Aortic valve bioprothesis considered is Edwards Sapien 3® et/ou XT®
  • Subject is ≥ 18 years of age
  • Subject has signed informed consent form

Exclusion Criteria:

  • Pregnancy
  • Subject already included in this study
  • Subject included in another study and whose inclusion in EASY TAVI implies a deviation in either study
  Contacts and Locations
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): NCT02781896


Contacts
Contact: Marina Mourot +33476707440 mourot.arc@gmail.com
Contact: Valérie ARMAND +33476285081 v.armand@ghm-grenoble.fr

Sponsors and Collaborators
Groupe Hospitalier Mutualiste de Grenoble
Centre Recherche Cardiovasculaire Alpes
Investigators
Principal Investigator: Benjamin Faurie Centre Recherche Cardio Vasculaire Alpes
Principal Investigator: Thierry Lefèvre Massy
  More Information

Publications:
Responsible Party: Groupe Hospitalier Mutualiste de Grenoble
ClinicalTrials.gov Identifier: NCT02781896     History of Changes
Other Study ID Numbers: EASY TAVI 2016
First Submitted: May 18, 2016
First Posted: May 25, 2016
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Groupe Hospitalier Mutualiste de Grenoble:
TAVI
aortic valve bioprothesis
TAVI simplification
aortic stenosis
rapid left ventricular pacing
TAVR

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction