Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation

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Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement Remote Ischemic Preconditioning for Renal Protection in TAVI Avr Thrombosis OutcoMe Study PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry Virtual Reality Assisted Conscious Sedation During TAVI The Aortic Valve DECalcification (AVADEC) Trial Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial) Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta. 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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. Pilot Study of Cognitive and Functional Outcomes Following TAVI Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement SOURCE XT REGISTRY Imaging Histone Deacetylase in the Heart A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement The PARTNER II Trial: S3iCAP Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development First in Man Study of the JenaValve TAVI Plus System Transfemoral Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR Ascending Aortic Dilation in BiAV After TAVR Safety and Performance Study of the Optimum Transcatheter Aortic Valve Transcatheter Aortic Valve Replacement With Extracorporeal Life System 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis 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Brief Title

Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation

Official Title

Protection of Heart, Brain and Kidney by Remote Ischemic Preconditioning in Patients Undergoing Transcatheter Aortic Valve Implantation - a Randomized, Single-blind Study

Brief Summary

      Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical
      practice, but concerns have been raised regarding periprocedural complications like e.g.
      myocardial injury, stroke or acute kidney injury. Remote ischemic preconditioning (RIPC) with
      upper limb ischemia/reperfusion provides perioperative myocardial protection in patients
      undergoing elective coronary artery bypass surgery. The present study assesses protection of
      heart, brain and kidney by RIPC in patients undergoing TAVI. The study also addresses safety
      and clinical outcome.

Detailed Description

      -  On the assumption of our recent data (Thielmann et al, Lancet 2013, 382(9892):597-604),
           we performed a power analysis, revealing an estimated enrollment of 189 patients per
           group. But since no true data exist regarding RIPC and TAVI, interim analysis will be
           performed after 50 patients per group.

        -  After induction of conscious sedation or general anaesthesia, RIPC is accomplished by 3
           cycles of 5 min inflation/5 min deflation of a blood pressure cuff around the left arm
           to 200 mm Hg. In the placebo group, the blood pressure cuff remains uninflated for 30
           min.

        -  Blind: study coordinators, outcome assessors, operators and treating physicians except
           for the attending anaesthetist.

        -  Drugs used for conscious sedation: midazolam, remifentanil.

        -  Drugs used for general anaesthesia: sufentanil, etomidate, rocuronium, isoflurane.

        -  TAVI is performed by standard techniques using the balloon-expandable Sapien XT (Edwards
           Lifesciences Inc., Irvine, California, USA) and the next-generation Sapien 3 stent-valve
           bioprosthesis which replaces the Sapien XT prosthesis, when CE-approved.

        -  Arterial blood samples are obtained prior to and after RIPC-maneuver/Placebo, after
           aortic valve implantation and after access site closure, for biochemical analyses
           focussing on ligands that have been previously implicated in conditioning protocols at
           various organs. A bioassay system, consisting of a Langendorff-perfused isolated heart
           with ischemia and reperfusion will be used. This bioassay system will be exposed to the
           obtained arterial plasma of the patients.

        -  Venous blood samples are drawn before TAVI and at 1, 6, 12, 24, 48 and 72 hours after
           the procedure.

        -  Cardiac and cerebral MRI is performed in selected patients at baseline and within the
           first week after TAVI.

        -  On-site follow-up at 3±3 months, 12±3 months and yearly thereafter.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Extent of periinterventional myocardial injury as reflected by the geometric mean of the area under the curve (AUC) for troponin I serum concentrations

Secondary Outcome

 Periprocedural myocardial infarction according to current Valve Academic Research Consortium (VARC-2) criteria

Condition

Aortic Valve Stenosis

Intervention

Remote ischemic preconditioning (RIPC)

Study Arms / Comparison Groups

 Remote ischemic preconditioning (RIPC)
Description:  RIPC-protocol before TAVI: after induction of conscious sedation/anesthesia, but prior to TAVI procedure, remote ischemic preconditioning (RIPC) protocol is performed, consisting of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion, followed by a time interval between the end of the last deflation and local groin anaesthesia with subsequent skin puncture of 30 min.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

September 2013

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients with severe symptomatic native aortic valve stenosis scheduled for
             elective TAVI due to a prohibitive or high risk for surgical aortic valve replacement
             as judged by the institutional heart team based on risk scores and comorbidity
             assessment

          -  Written informed consent

        Exclusion Criteria:

          -  Life expectancy < 1 year

          -  Patients who are unlikely to gain improvement in their quality of life by TAVI
             procedure

          -  Unfavorable anatomy for TAVI (e.g. inadequate annulus size)

          -  Left-ventricular thrombus

          -  Active endocarditis

          -  Active infection

          -  Acute ST-segment elevation myocardial infarction

          -  Hemodynamic instability

          -  Preoperative troponin I concentration above the upper normal limit of 0.1 ng/ml

          -  Stroke within the last 6 weeks

          -  Acute or chronic hemodialysis

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Philipp Kahlert, MD, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT02080299

Organization ID

135355-BO

Responsible Party

Principal Investigator

Study Sponsor

University Hospital, Essen

Collaborators

 Koblenz University of Applied Science

Study Sponsor

Philipp Kahlert, MD, Principal Investigator, Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen

Verification Date

November 2016