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Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement (COMPLETE TAVR)

Primary Purpose

Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention (PCI)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Coronary Artery Disease, Aortic Stenosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women with severe symptomatic aortic valve stenosis defined as: [aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2] AND [Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg] AND [NYHA Functional Class ≥ 2 OR abnormal exercise test with severe SOB, abnormal blood pressure response, or arrhythmia]

AND

  • Coronary artery disease defined as: (at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment that is at least 2.5 mm in diameter that is not a CTO and is amenable to treatment with percutaneous coronary intervention (PCI))

AND

  • Consensus by the Multidisciplinary Heart Team that the patient is suitable for elective transfemoral transcatheter aortic valve replacement (TAVR) with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing surgical aortic valve replacement.

AND

  • Successful TAVR defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications

Exclusion Criteria:

  • PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
  • Planned PCI of coronary artery lesion(s)
  • Planned surgical revascularization of coronary artery lesion(s)
  • Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
  • Any factor precluding 5-year follow-up
  • Prior coronary artery bypass grafting surgery or surgical valve replacement
  • Severe mitral regurgitation (> 3+)
  • Severe left ventricular dysfunction (LVEF < 30%)
  • Low coronary takeoff (high risk for coronary obstruction)
  • Acute myocardial infarction within 90 days
  • Stroke or transient ischemic attack within 90 days
  • Renal insufficiency (eGFR < 30 ml/min) and/or renal replacement Rx
  • Hemodynamic or respiratory instability

Sites / Locations

  • Huntsville Heart CenterRecruiting
  • Arizona Cardiovascular ResearchRecruiting
  • Veteran Affairs Palo Alto Health Care SystemRecruiting
  • Loma Linda UniversityRecruiting
  • Torrance Memorial Medical CenterRecruiting
  • JFK Medical CenterRecruiting
  • Baptist Health JacksonvilleRecruiting
  • Miami Cardiac and Vascular/Baptist HospitalRecruiting
  • PiedmontRecruiting
  • Northeast Georgia Health SystemRecruiting
  • St. Alphonsus Regional Medical CenterRecruiting
  • Ascension Alexian BrothersRecruiting
  • Midwest Cardiovascular Research and Education FoundationRecruiting
  • Parkview Research CenterRecruiting
  • University of Kansas Medical CenterRecruiting
  • Midwest Heart and VascularRecruiting
  • Cardiovascular Research Institute of KansasRecruiting
  • Tufts MedicalRecruiting
  • Massachusetts General HospitalRecruiting
  • Sparrow Clinical Research InstituteRecruiting
  • William Beaumont HospitalRecruiting
  • Ascension St. Mary'sRecruiting
  • St. Joseph Mercy Health SystemRecruiting
  • University of Minnesota Medical CenterRecruiting
  • CentraCare Heart and Vascular CenterRecruiting
  • Boone HospitalRecruiting
  • Missouri BaptistRecruiting
  • Bryan HeartRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • Our Lady of LourdesRecruiting
  • University at BuffaloRecruiting
  • NYU Langone Hospital - Long IslandRecruiting
  • Mount SinaiRecruiting
  • Columbia University Medical CenterRecruiting
  • St. Joseph's HospitalRecruiting
  • Novant Health Heart and Vascular InstituteRecruiting
  • Summa Health SystemRecruiting
  • Mount CarmelRecruiting
  • Oklahoma HeartRecruiting
  • Kaiser Permanente NorthwestRecruiting
  • Rhode Island HospitalRecruiting
  • Methodist Le Bonheur HealthcareRecruiting
  • Ballad Health CVA Heart InstituteRecruiting
  • Parkwest Medical CenterRecruiting
  • Cardiovascular Surgery Clinic/Baptist MemorialRecruiting
  • HCA Houston Healthcare Medical CenterRecruiting
  • Baylor Scott & White PlanoRecruiting
  • Baylor Scott & White Round RockRecruiting
  • Bellin Health SystemRecruiting
  • Ascension Columbia St. Mary'sRecruiting
  • University of Alberta, Mazankowski Heart InstituteRecruiting
  • Royal Columbian HospitalRecruiting
  • Vancouver General HospitalRecruiting
  • Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)
  • St. Paul's HospitalRecruiting
  • Saint BonifaceRecruiting
  • Queen Elizabeth II Health Sciences CentreRecruiting
  • Hamilton Health SciencesRecruiting
  • Ottawa HeartRecruiting
  • Sunnybrook HospitalRecruiting
  • St. Michael's HospitalRecruiting
  • Montréal HeartRecruiting
  • Centre Hospitalier de l'Université de MontréalRecruiting
  • CIUSSS de l'Estrie-CHUSRecruiting
  • Prairie VascularRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Complete Revascularization

Medical Therapy Alone

Arm Description

Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.

No revascularization of coronary artery lesions.

Outcomes

Primary Outcome Measures

Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure

Secondary Outcome Measures

Cardiovascular Death or New Myocardial Infarction
Deaths will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular. Myocardial Infarction will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial.
Transaortic gradient immediately post-TAVR (echocardiographically-derived vs. direct invasive measurement)
Transaortic Gradient Reclassification
Proportion of patients developing echocardiographic aortic gradient ≥20 mmHg who are found to have a gradient < 20 mmHg on direct hemodynamic assessment.
VARC-3 Hemodynamic Valve Deterioration Reclassification
Proportion of patients developing ≥ moderate echocardiographic VARC-3 valve deterioration reclassified to < moderate VARC-3 valve deterioration using direct invasive methods, including mean gradient and valve area.
Severe Patient Prosthesis Mismatch (PPM) Reclassification
Proportion of patients with echocardiographic severe PPM immediately post-TAVR, reclassified as non-severe PPM using direct invasive methods.
Composite of CV Death, New MI, IDR or Hospitalization for UA or for HF in patients with PPM and elevated gradients vs those without
Deaths: will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular. Myocardial Infarction: will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial. Hospital admission: for protocol-defined unstable angina, new/worsening NYHA Class IV heart failure, or for protocol-defined Ischemia-driven revascularization, among patients with patient prosthesis mismatch (PPM), elevated echocardiography-derived transaortic gradients and elevated direct invasive transaortic gradient vs those without.
Composite outcome of mean echocardiographic gradient ≥ 20mmHg, severe PPM, ≥ moderate AR, thrombosis, endocarditis, and aortic valve re-intervention
Cardiovascular Death
New Myocardial Infarction
Ischemia-Driven Revascularization
Hospitalization for Unstable Angina or Heart Failure
All-cause Mortality
Includes deaths from both cardiac and non-cardiac causes
Stroke
Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as CT scan or MRI be performed. Stroke will be further classified as ischemic, hemorrhagic or type uncertain.
Bleeding
Clinically overt, symptomatic bleeding with at least one of the following criteria: Fatal, or Symptomatic intracranial hemorrhage, or Retroperitoneal hemorrhage, or Intraocular hemorrhage leading to significant vision loss, or Decrease in hemoglobin of 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL of Hb) or requiring transfusion of two or more units of red blood cells or equivalent of whole blood. Requiring surgical intervention to stop the bleeding
Angina status
As evaluated by the Seattle Angina Questionnaire
Economic evaluation
Includes health resource utilization, costs, and cost-effectiveness
Patient-reported outcomes
Health-related quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire at baseline, 30 days, 6 months, 1 year, and annually thereafter.
Contrast-associated acute kidney injury
An absolute rise in serum creatinine of greater than or equal to 44 μmol/L from baseline and/or a relative rise in serum creatinine of ≥25% compared to baseline at any time between 48hrs and 96hrs post-procedure.
Fluoroscopic time for Staged PCI procedure
Total time under fluoroscopy
Contrast Utilization for Stages PCI Procedure

Full Information

First Posted
November 16, 2020
Last Updated
May 30, 2023
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04634240
Brief Title
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Acronym
COMPLETE TAVR
Official Title
A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization With Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients With Symptomatic Aortic Valve Stenosis Undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2020 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis
Keywords
Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Coronary Artery Disease, Aortic Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complete Revascularization
Arm Type
Experimental
Arm Description
Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.
Arm Title
Medical Therapy Alone
Arm Type
No Intervention
Arm Description
No revascularization of coronary artery lesions.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention (PCI)
Intervention Description
PCI of all qualifying lesions.
Primary Outcome Measure Information:
Title
Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure
Time Frame
Median follow-up of 3.5 years
Secondary Outcome Measure Information:
Title
Cardiovascular Death or New Myocardial Infarction
Description
Deaths will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular. Myocardial Infarction will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial.
Time Frame
Median follow-up of 3.5 years
Title
Transaortic gradient immediately post-TAVR (echocardiographically-derived vs. direct invasive measurement)
Time Frame
Immediately post-TAVR
Title
Transaortic Gradient Reclassification
Description
Proportion of patients developing echocardiographic aortic gradient ≥20 mmHg who are found to have a gradient < 20 mmHg on direct hemodynamic assessment.
Time Frame
Median follow-up of 3.5 years
Title
VARC-3 Hemodynamic Valve Deterioration Reclassification
Description
Proportion of patients developing ≥ moderate echocardiographic VARC-3 valve deterioration reclassified to < moderate VARC-3 valve deterioration using direct invasive methods, including mean gradient and valve area.
Time Frame
Median follow-up of 3.5 years
Title
Severe Patient Prosthesis Mismatch (PPM) Reclassification
Description
Proportion of patients with echocardiographic severe PPM immediately post-TAVR, reclassified as non-severe PPM using direct invasive methods.
Time Frame
Median follow-up of 3.5 years
Title
Composite of CV Death, New MI, IDR or Hospitalization for UA or for HF in patients with PPM and elevated gradients vs those without
Description
Deaths: will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular. Myocardial Infarction: will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial. Hospital admission: for protocol-defined unstable angina, new/worsening NYHA Class IV heart failure, or for protocol-defined Ischemia-driven revascularization, among patients with patient prosthesis mismatch (PPM), elevated echocardiography-derived transaortic gradients and elevated direct invasive transaortic gradient vs those without.
Time Frame
Median follow-up of 3.5 years
Title
Composite outcome of mean echocardiographic gradient ≥ 20mmHg, severe PPM, ≥ moderate AR, thrombosis, endocarditis, and aortic valve re-intervention
Time Frame
Median follow-up of 3.5 years
Title
Cardiovascular Death
Time Frame
Median follow-up of 3.5 years
Title
New Myocardial Infarction
Time Frame
Median follow-up of 3.5 years
Title
Ischemia-Driven Revascularization
Time Frame
Median follow-up of 3.5 years
Title
Hospitalization for Unstable Angina or Heart Failure
Time Frame
Median follow-up of 3.5 years
Title
All-cause Mortality
Description
Includes deaths from both cardiac and non-cardiac causes
Time Frame
Median follow-up of 3.5 years
Title
Stroke
Description
Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as CT scan or MRI be performed. Stroke will be further classified as ischemic, hemorrhagic or type uncertain.
Time Frame
Median follow-up of 3.5 years
Title
Bleeding
Description
Clinically overt, symptomatic bleeding with at least one of the following criteria: Fatal, or Symptomatic intracranial hemorrhage, or Retroperitoneal hemorrhage, or Intraocular hemorrhage leading to significant vision loss, or Decrease in hemoglobin of 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL of Hb) or requiring transfusion of two or more units of red blood cells or equivalent of whole blood. Requiring surgical intervention to stop the bleeding
Time Frame
Median follow-up of 3.5 years
Title
Angina status
Description
As evaluated by the Seattle Angina Questionnaire
Time Frame
Median follow-up of 3.5 years
Title
Economic evaluation
Description
Includes health resource utilization, costs, and cost-effectiveness
Time Frame
Median follow-up of 3.5 years
Title
Patient-reported outcomes
Description
Health-related quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire at baseline, 30 days, 6 months, 1 year, and annually thereafter.
Time Frame
Median follow-up of 3.5 years
Title
Contrast-associated acute kidney injury
Description
An absolute rise in serum creatinine of greater than or equal to 44 μmol/L from baseline and/or a relative rise in serum creatinine of ≥25% compared to baseline at any time between 48hrs and 96hrs post-procedure.
Time Frame
Median follow-up of 3.5 years
Title
Fluoroscopic time for Staged PCI procedure
Description
Total time under fluoroscopy
Time Frame
During PCI procedure
Title
Contrast Utilization for Stages PCI Procedure
Time Frame
During PCI procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women with severe symptomatic aortic valve stenosis defined as: [aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2] AND [Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg] AND [NYHA Functional Class ≥ 2 OR abnormal exercise test with severe SOB, abnormal blood pressure response, or arrhythmia] AND Coronary artery disease defined as: (at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment that is at least 2.5 mm in diameter that is not a CTO and is amenable to treatment with percutaneous coronary intervention (PCI)) AND Consensus by the Multidisciplinary Heart Team that the patient is suitable for elective transfemoral transcatheter aortic valve replacement (TAVR) with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing surgical aortic valve replacement. AND Successful TAVR defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications Exclusion Criteria: PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure Planned PCI of coronary artery lesion(s) Planned surgical revascularization of coronary artery lesion(s) Non-cardiovascular co-morbidity reducing life expectancy to < 5 years Any factor precluding 5-year follow-up Prior coronary artery bypass grafting surgery or surgical valve replacement Severe mitral regurgitation (> 3+) Severe left ventricular dysfunction (LVEF < 30%) Low coronary takeoff (high risk for coronary obstruction) Acute myocardial infarction within 90 days Stroke or transient ischemic attack within 90 days Renal insufficiency (eGFR < 30 ml/min) and/or renal replacement Rx Hemodynamic or respiratory instability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brady J Robinson, CCRP
Phone
604-875-4111
Ext
22936
Email
brobinson@cci-cic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Wood, MD
Organizational Affiliation
CCI-CIC, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsville Heart Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Vasquez, MD
Facility Name
Arizona Cardiovascular Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hursh Naik, MD
Facility Name
Veteran Affairs Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celina Yong, MD
Facility Name
Loma Linda University
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Jutzy, MD
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salman Azam, MD
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Rothenberg, MD
Facility Name
Baptist Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidd Wayangankar, MD
Facility Name
Miami Cardiac and Vascular/Baptist Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon Quesada
Facility Name
Piedmont
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav, MD
Facility Name
Northeast Georgia Health System
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronnie Ramadan
Facility Name
St. Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83709
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Walsh, MD
Facility Name
Ascension Alexian Brothers
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrei Pop, MD
Facility Name
Midwest Cardiovascular Research and Education Foundation
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Troy Weirick, MD
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy W Robertson, MD
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Tadros, MD
Facility Name
Midwest Heart and Vascular
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bangalore Deepak, MD
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem Chehab, MD
Facility Name
Tufts Medical
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Resor, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilay Patel, MD
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Qintar, MD
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Abbas, MD
Facility Name
Ascension St. Mary's
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safwan Kassas, MD
Facility Name
St. Joseph Mercy Health System
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansoor A Qureshi, MD
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Helmer, MD
Facility Name
CentraCare Heart and Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thom Dahle, MD
Facility Name
Boone Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joss Fernandez, MD
Facility Name
Missouri Baptist
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gus Theodos, MD
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Johnson, MD
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James DeVries, MD
Facility Name
Our Lady of Lourdes
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Moussa, MD
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, MD
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Schwartz, DO
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samin Sharma, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10552
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Ng, MD
Facility Name
St. Joseph's Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayman Iskander, MD
Facility Name
Novant Health Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oluseun Alli, MD
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Bittenbender, MD
Facility Name
Mount Carmel
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Jones, MD
Facility Name
Oklahoma Heart
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Ghani, MD
Facility Name
Kaiser Permanente Northwest
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhimanyu Uberoi
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Gordon, MD
Facility Name
Methodist Le Bonheur Healthcare
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehul Patel, MD
Facility Name
Ballad Health CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Aziz, MD
Facility Name
Parkwest Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayaz Rahman, MD
Facility Name
Cardiovascular Surgery Clinic/Baptist Memorial
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38671
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basil Paulus, MD
Facility Name
HCA Houston Healthcare Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pranav Loyalka, MD
Facility Name
Baylor Scott & White Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srini Potluri, MD
Facility Name
Baylor Scott & White Round Rock
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Condado, MD
Facility Name
Bellin Health System
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Ricci
Facility Name
Ascension Columbia St. Mary's
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Stair, MD
Facility Name
University of Alberta, Mazankowski Heart Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Welsh, MD
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Chan, MD
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Chow
Phone
604-875-5324
Facility Name
Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brady J Robinson, CCRP
Phone
604-875-4111
Ext
22936
Email
brobinson@cci-cic.org
First Name & Middle Initial & Last Name & Degree
David A Wood, MD
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Grieve
Phone
604-682-2344
Ext
64980
Facility Name
Saint Boniface
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malek Kass, MD
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama ElKhateeb, MD
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tej Sheth, MD
Facility Name
Ottawa Heart
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Dick, MD
Facility Name
Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Radhakrishnan
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Fam, MD
Facility Name
Montréal Heart
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Asgar, MD
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Bernard Masson
Facility Name
CIUSSS de l'Estrie-CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5H3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit Daneault, MD
Facility Name
Prairie Vascular
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Payam Dehghani, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

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