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Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)

NCT ID: NCT03283501

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-20

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Transcatheter Valve Implantation TAVI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Luigi Gonzaga Hospital

OTHER

Sponsor Role lead

Responsible Party

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Enrico Cerrato

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Humanitas Research Hospital, Humanitas University

Rozzano, Milan, Italy

Site Status RECRUITING

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy

Turin, , Italy

Site Status RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Countries

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Italy Spain

Facility Contacts

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Giulio Stefanini, MD, PhD

Role: primary

[email protected]
+390282241

Enrico Cerrato, MD

Role: primary

[email protected]
+390119026602

Luis Nombela-Franco, MD,PhD

Role: primary

[email protected]
+34 91 330 30 00

References

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Stefanini GG, Cerrato E, Pivato CA, Joner M, Testa L, Rheude T, Pilgrim T, Pavani M, Brouwer J, Lopez Otero D, Munoz Garcia E, Barbanti M, Biasco L, Varbella F, Reimers B, Jimenez Diaz VA, Leoncini M, Salido Tahoces ML, Ielasi A, de la Torre Hernandez JM, Mylotte D, Garot P, Chieffo A, Nombela-Franco L; REVIVAL Investigators. Unplanned Percutaneous Coronary Revascularization After TAVR: A Multicenter International Registry. JACC Cardiovasc Interv. 2021 Jan 25;14(2):198-207. doi: 10.1016/j.jcin.2020.10.031.

Reference Type DERIVED
PMID: 33478637 (View on PubMed)

Related Links

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http://cardiogroup.org

Organization research website

Other Identifiers

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001-2017

Identifier Type: -

Identifier Source: org_study_id

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