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

Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: pacing catheter; Device: valve delivery guidewire

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
      • Chu Clermont Ferrand
    • Epagny, Auvergne-Rhône-Alpes, France, 74370
      • Centre Hospitalier Annecy Genevois
    • Villeurbanne, Auvergne-Rhône-Alpes, France, 69100
      • Clinique du Tonkin
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Institut Mutualiste Montsouris
  • Isère
    • Grenoble, Isère, France, 38028
      • Groupement Hospitalier Mutualiste de Grenoble
  • Massy
    • Paris, Massy, France, 91300
      • Hôpital Privé Jacques Cartier
  • Normandie
    • Rouen, Normandie, France, 76000
      • Clinique Saint-Hilaire
  • Occitanie
    • Toulouse, Occitanie, France, 31300
      • Clinique Pasteur
  • Provence-Alpes-Côte d'Azur
    • Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur, France, 06721
      • Institut Arnault Tzanck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total TAVI procedural duration	Duration of TAVI procedure is calculated from the first puncture to the last sheath removal	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency)	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.	1 month
Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety)	Safety includes success of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades	1 month
Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness)	Study costs includes direct costs (material used for the rapid pacing) and indirect costs (medical complications)	1 month

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Mutualiste de Grenoble
• Collaborators: Centre Recherche Cardio Vasculaire Alpes
• Investigators: Principal Investigator: Benjamin Faurie, Centre Recherche Cardio Vasculaire Alpes; Principal Investigator: Thierry Lefèvre, Massy

Publications and helpful links

General Publications

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
• Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
• Arnold SV, Reynolds MR, Wang K, Magnuson EA, Baron SJ, Chinnakondepalli KM, Reardon MJ, Tadros PN, Zorn GL, Maini B, Mumtaz MA, Brown JM, Kipperman RM, Adams DH, Popma JJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1207-1217. doi: 10.1016/j.jcin.2015.04.018.
• Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
• Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004 Feb 18;43(4):698-703. doi: 10.1016/j.jacc.2003.11.026.
• Eggebrecht H, Mehta RH, Kahlert P, Schymik G, Lefevre T, Lange R, Macaya C, Mandinov L, Wendler O, Thomas M. Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): insights from the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry. EuroIntervention. 2014 Dec;10(8):975-81. doi: 10.4244/EIJV10I8A165.
• Faurie B, Abdellaoui M, Wautot F, Staat P, Champagnac D, Wintzer-Wehekind J, Vanzetto G, Bertrand B, Monsegu J. Rapid pacing using the left ventricular guidewire: Reviving an old technique to simplify BAV and TAVI procedures. Catheter Cardiovasc Interv. 2016 Nov 15;88(6):988-993. doi: 10.1002/ccd.26666. Epub 2016 Aug 11.
• Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.
• Karagoz T, Aypar E, Erdogan I, Sahin M, Ozer S, Celiker A. Congenital aortic stenosis: a novel technique for ventricular pacing during valvuloplasty. Catheter Cardiovasc Interv. 2008 Oct 1;72(4):527-30. doi: 10.1002/ccd.21695.
• Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schachinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.
• Navarini S, Pfammatter JP, Meier B. Left ventricular guidewire pacing to simplify aortic balloon valvuloplasty. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):426-7. doi: 10.1002/ccd.21810. No abstract available.
• Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.
• Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, Wendler O. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011 Jul 26;124(4):425-33. doi: 10.1161/CIRCULATIONAHA.110.001545. Epub 2011 Jul 11.
• Walther T, Hamm CW, Schuler G, Berkowitsch A, Kotting J, Mangner N, Mudra H, Beckmann A, Cremer J, Welz A, Lange R, Kuck KH, Mohr FW, Mollmann H; GARY Executive Board. Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry. J Am Coll Cardiol. 2015 May 26;65(20):2173-80. doi: 10.1016/j.jacc.2015.03.034. Epub 2015 Mar 15.
• Wenaweser P, Pilgrim T, Roth N, Kadner A, Stortecky S, Kalesan B, Meuli F, Bullesfeld L, Khattab AA, Huber C, Eberle B, Erdos G, Meier B, Juni P, Carrel T, Windecker S. Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes. Am Heart J. 2011 Jun;161(6):1114-24. doi: 10.1016/j.ahj.2011.01.025. Epub 2011 May 11.
• Vogel R, Meier B. Emergent mechanical and electrical guidewire pacing of the right ventricle for aystole in the cardiac catheterization laboratory. J Invasive Cardiol. 2005 Sep;17(9):490. No abstract available.
• Faurie B, Souteyrand G, Staat P, Godin M, Caussin C, Van Belle E, Mangin L, Meyer P, Dumonteil N, Abdellaoui M, Monsegu J, Durand-Zaleski I, Lefevre T; EASY TAVI Investigators. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2449-2459. doi: 10.1016/j.jcin.2019.09.029. Epub 2019 Sep 28.

Helpful Links

• Guerios EE, W. P. (2013). Left ventricular guidewire pacing for transcatheter aortic valve implantation. CCI, E919-21.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2017
• Primary Completion (ACTUAL): June 29, 2018
• Study Completion (ACTUAL): June 29, 2018

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (ESTIMATE): May 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: aortic stenosis; TAVI; TAVR; aortic valve bioprothesis; TAVI simplification; rapid left ventricular pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: EASY TAVI 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No