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

NCT02781896 | Completed DMC

• 1 other identifier: EASY TAVI 2016
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Aortic Valve Stenosis

Keywords

TAVI; aortic valve bioprothesis; TAVI simplification; aortic stenosis; rapid left ventricular pacing; TAVR

Outcome Measures

Primary Outcomes (1)

• Total TAVI procedural duration

  Duration of TAVI procedure is calculated from the first puncture to the last sheath removal

  1 month

Secondary Outcomes (3)

• Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency)

  1 month

• Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety)

  1 month

• Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness)

  1 month

Study Arms (2)

Right ventricular pacing

ACTIVE COMPARATOR

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

Left ventricular pacing

EXPERIMENTAL

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

Interventions

pacing catheter DEVICE

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.

Also known as: transvenous stimulation electrode, pacing lead, pacing wire

Right ventricular pacing

valve delivery guidewire DEVICE

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).

Left ventricular pacing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Subject already included in this study

Sponsors & Collaborators

• Groupe Hospitalier Mutualiste de Grenoble: lead
• Centre Recherche Cardio Vasculaire Alpes: collaborator

Study Sites (9)

CHU Clermont Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

Location

Centre Hospitalier Annecy Genevois

Épagny, Auvergne-Rhône-Alpes, 74370, France

Location

Clinique du Tonkin

Villeurbanne, Auvergne-Rhône-Alpes, 69100, France

Location

Groupement Hospitalier Mutualiste de Grenoble

Grenoble, Isère, 38028, France

Location

Hôpital privé Jacques Cartier

Paris, Massy, 91300, France

Location

Clinique Saint-Hilaire

Rouen, Normandy, 76000, France

Location

Clinique Pasteur

Toulouse, Occitanie, 31300, France

Location

Institut Arnault Tzanck

Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, 06721, France

Location

Institut Mutualiste Montsouris

Paris, Île-de-France Region, 75014, France

Location

Related Publications (18)

• 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.

  PMID: 24678937 BACKGROUND

• 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.

  PMID: 26292584 BACKGROUND

• 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.

  PMID: 12473543 BACKGROUND

• 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.

  PMID: 14975485 BACKGROUND

• 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.

  PMID: 24235321 BACKGROUND

• 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.

  PMID: 27510946 BACKGROUND

• 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.

  PMID: 22551129 BACKGROUND

• 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.

  PMID: 18814234 BACKGROUND

• 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.

  PMID: 21075775 BACKGROUND

• 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.

  PMID: 20961243 BACKGROUND

• 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.

  PMID: 19213097 BACKGROUND

• 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.

  PMID: 24657695 BACKGROUND

• 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.

  PMID: 21639811 BACKGROUND

• 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.

  PMID: 21747054 BACKGROUND

• 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.

  PMID: 25787198 BACKGROUND

• 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.

  PMID: 21641358 BACKGROUND

• 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.

  PMID: 16145240 BACKGROUND

• 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.

  PMID: 31857014 DERIVED

Related Links

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

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Benjamin Faurie

  Centre Recherche Cardio Vasculaire Alpes

  PRINCIPAL INVESTIGATOR

• Thierry Lefèvre

  Massy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 25, 2016
• Study Start: May 12, 2017
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)