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NCT03283501 Clinical Trial

Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)

TAVI Clinical Trial

— REVIVAL  

Official title:
A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03283501
Other study ID # 001-2017
Secondary ID
Status Recruiting
Phase N/A
First received September 4, 2017
Last updated September 12, 2017
Start date April 20, 2017
Est. completion date December 31, 2017

Study information
Verified date September 2017
Source San Luigi Gonzaga Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Description:

The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series.

Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Objectives

1. Evaluate the incidence of PCI after TAVI

2. Evaluate the clinical indications for PCI after TAVI

3. Evaluate the technical feasibility of PCI in patients with prior TAVI

4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PCI after TAVI
Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI

Locations
Country Name City State
Italy Humanitas Research Hospital, Humanitas University Rozzano Milan
Italy Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy Turin
Spain Hospital Clinico San Carlos Madrid

Sponsors (1)
Lead Sponsor Collaborator
San Luigi Gonzaga Hospital

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the incidence of PCI after TAVI Evaluate the incidence of PCI after TAVI up to 5 year after TAVI implantation
Primary Evaluate the clinical indications for PCI after TAVI Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction intraoperative
Primary Evaluate the technical feasibility of PCI in patients with prior TAVI Successful target coronary vessel revascularization intraoperative
Primary Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure up to 5 year after TAVI implantation
See also
  Status Clinical Trial Phase
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Active, not recruiting NCT03058627 - Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation N/A
Recruiting NCT05235555 - EffecTAVI Registry
Not yet recruiting NCT05914051 - PRELOAD-TAVI Trial N/A
Active, not recruiting NCT03338582 - STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI N/A
Active, not recruiting NCT03424941 - The TransCatheter Valve and Vessels Trial N/A
Recruiting NCT06189976 - Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation N/A
Active, not recruiting NCT04298593 - Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study N/A
Completed NCT03966417 - Exercise Training After Transcatheter Aortic Valve Implantation N/A
Completed NCT04286893 - Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Recruiting NCT04831957 - Hypothyroidism After the TAVI Procedure in Elderly Patients N/A
Completed NCT01759563 - Oxygenation of the Cerebrum and Cooling During TAVI - Part I Phase 3
Not yet recruiting NCT05617196 - Virtual PREHAB Study for Patients Undergoing TAVI N/A
Active, not recruiting NCT02700633 - Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI N/A
Not yet recruiting NCT04083040 - Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI) N/A

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