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