Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation

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.

Conditions

• Aortic Valve Stenosis

Interventions

PROCEDURE

Remote ischemic preconditioning (RIPC)

3 circles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion, preceding TAVI procedure.

PROCEDURE

Placebo

Prior to TAVI-procedure, the blood pressure cuff remains uninflated for 30 min.

Sponsors & Collaborators

• Koblenz University of Applied Science

  collaborator OTHER

• University Hospital, Essen

  lead OTHER

Principal Investigators

• Philipp Kahlert, MD · Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen

• Matthias Thielmann, MD · Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen

• Petra Kleinbongard, PhD · Institute of Pathophysiology, University Duisburg-Essen

• Eva Kottenberg, MD · Clinic for Anesthesiology and Intensive Care Medicine, University Duisburg-Essen

• Jürgen Peters, MD · Clinic for Anesthesiology and Intensive Care Medicine, University Duisburg-Essen

• Heinz Jakob, MD · Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen

• Raimund Erbel, MD · Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen

• Gerd Heusch, MD, PhD · Institute of Pathophysiology, University Duisburg-Essen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• Germany

Study Locations