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Research


 

TELEFLEX-CTO-PCI

Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study

This is an IDE study to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used. The data captured in this study will be used to support U.S. Food and Drug Administration (FDA) 510(k) clearance for CTO indications. 

The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll up to 150 patients to provide adequate powering for hypothesis testing and an evaluable sample size of at least 135 patients

Patients will be followed until discharge post index procedure.

SPONSOR: Vascular Solutions LLC

Principal Investigator: Dr. Wyman

Current Study Status:  Enrollment to begin April –May 2020

Link to clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03988166?term=cto+teleflex&draw=2&rank=1

 

FROZEN AF

Safety and Effectiveness IDE trial for Boston Scientific’s Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

This is a Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific’s Cryoablation System. All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for twelve (12) months after the index procedure. 

A maximum of 405 subjects treated with the Cryoablation System will be enrolled in the study, inclusive of a maximum of 80 roll-in TREATMENT subjects and 325 non roll-in TREATMENT subjects.

Up to 50 sites will participate

SPONSOR: Boston Scientific Corporation

Principal Investigator: Dr. Ji

Sub-Investigators:  Dr. Kosar 

Current Study Status:  Enrollment to begin April 2020 

Link to clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT04133168?term=frozen+af&draw=2&rank=1

 

INTERRUPT AF

This is a prospective evaluation of open irrigated ablation catheters with high resolution mapping to treat paroxysmal atrial fibrillation

The study objectives are:

To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.

Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open- Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical). 

Subjects will be followed for approximately 36 months after the baseline visit

Up to 415 will be enrolled across up to 50 site in the US, Europe and Asia Pacific 

SPONSOR: Boston Scientific Corporation

Principal Investigator: Dr. Ji

Sub-Investigators:  Dr. Ostrom, Dr. Kim 

Current Study Status:  Enrolling 

Link to clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03729830?term=interrupt+af&draw=2&rank=1 

 

PREEMPT HF

This is a post-market study.  The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogicTM Heart Failure Diagnostic (HeartLogicTM) in a broad spectrum of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).

The primary objective of the PREEMPT-HF study is to investigate the association between HF sensor data and 30-day HF readmissions. 

Subjects will be followed for approximately 12 months after the baseline visit to collect the required number of clinical events to support the study objectives. These events are called Reviewable Clinical Events (RCEs), and include all-cause hospitalizations and HF outpatient visits.

The required protocol study visits and medical record reviews are as follows:

  • Enrollment visit
  • Baseline visit
  • Interim medical record review (6 month, does not require a clinic visit)
  • Final clinic visit (12 month, or at the point of withdrawal)

Subjects will exit the study following their final clinic visit.

Up to 3750 subjects will be enrolled across up to 200 sites in the US, Canada, Europe and Asia Pacific 

SPONSOR: Boston Scientific Corporation

Principal Investigator: Dr. Ostrom

Sub-Investigators:  Dr. Lurie, Dr. Ji, Dr. Kosar, Dr. Kim

Current Study Status:  Enrollment open 

Link to clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03579641?term=NCT03579641&rank=1

 

ISCHEMIA

ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches)

This is an international comparative effectiveness study. Participants will be recruited following clinically indicated stress testing but before catheterization and randomized in a 1:1 fashion to an invasive or optimal medical management strategy. Approximately 8000 participants randomized which will require pre-eligibility screening, CCTA visit, randomization, 1.5 months, 3 months, 6 months, 12 months, and every 6 months thereafter with approximate 4 year follow up.

SPONSOR: NHLBI, New York University School of Medicine

Principal Investigator: Dr. Wyman

Sub-Investigators:  Dr. Chhabra, Dr. Grabb, Dr. Lurie, Dr. Reddy, Dr. Stoneburner

Current Study Status:  Enrollment closed, Study closed 

https://clinicaltrials.gov/ct2/show/NCT03108456?term=nct03108456&rank=1

 

CONNECT HF

CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.

Outcomes will be assessed in the year following discharge for participants hospitalized with acute HF and history of reduced left ventricular ejection fraction. All participants in the trial will be consented as part of the CONNECT-HF registry on clinical outcomes, medication use, and participant-centered outcomes, including quality-of-life (QOL) assessments, at 6 weeks and 3, 6, and 12 months after discharge, for longitudinal follow-up.

The health-system QI program will involve site visits and ongoing mentoring from teams of healthcare professionals with specialized training and field experience to help health systems and individual hospitals to design local QI plans.

A key sub-study will assess a participant-engagement strategy (digital) of a mobile application utilizing behavioral tools to reinforce health behaviors, including self-monitoring/self-management and medication adherence.

Follow-up will occur via a centralized telephone interview by trained personnel via the DCRI Call Center. At each interview, participants will be asked to report current medications, re-hospitalizations, and QOL assessments. Based on participant-reported events, medical billing data for re-hospitalizations, emergency department visits, and procedures will be obtained.

SPONSOR: Adam DeVore, MD at Duke University/Duke Clinical Research Institute

Principal Investigator: Dr. Lurie

Sub-Investigators:  Dr. Chhabra, Roxanna Balter, NP

Current Study Status:  Enrollment Open

Link to clinicaltrials.gov:  https://clinicaltrials.gov/ct2/show/NCT03035474?term=NCT03035474&rank=1

 

XIENCE 90

XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents.

Subjects will be followed post implant at 3 months, 6 months, and at 12 months.  Approximately 2,250 subjects  total patients will be enrolled globally

SPONSOR: Abbott Cardiovascular Systems, Inc.

Principal Investigator: Dr. Wyman

Sub-Investigators:  Dr. Chhabra, Dr. Azam, Dr. Matchison 

Current Study Status:  Enrollment closed, Patients in follow up

Link to clinicaltrials.gov:  https://clinicaltrials.gov/ct2/show/NCT03218787?term=NCT03218787&rank=1

 

ABSORB III

This is a prospective, randomized, single-blind, multi-center trial to evaluate the safety and effectiveness of Absorb™ Bioresorbable Vascular Scaffold (BVS) in the treatment of subjects with de novo native coronary artery lesions. 

All subjects in the ABSORB III will receive the following clinical follow-up post implant:

30 days, 180 days, 1 year and annual visits up to 5 years. 

SPONSOR: Abbott Cardiovascular Systems, Inc.

Principal Investigator: Dr. Wyman

Sub-Investigators:  Dr. Chhabra, Dr. Azam, Dr. Matchison 

Current Study Status:  Enrollment Closed, No subject follow-up

Link to clinicaltrials.gov:  https://clinicaltrials.gov/ct2/show/NCT01751906?term=absorb+III+RCT&rank=2

 

ABSORB IV

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System as compared to the commercially approved, control stent XIENCE. 

Subjects will be followed post implant at 30 days, 90 days, 180 days, 270 days, 1, year, 2 years, 3 years, 4 years and 5 years. 

300 subjects at approximately 140 global sites were enrolled. 

SPONSOR: Abbott Cardiovascular Systems, Inc.

Principal Investigator: Dr. Wyman

Sub-Investigators:  Dr. Chhabra, Dr. Azam, Dr. Matchison 

Current Study Status:  Enrollment Closed, Subjects in Follow-up Phase

Link to clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02173379?term=absorb+IV&rank=1

 

ATTAIN STABILITY QUAD

The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, Investigational Device Exemption (IDE) interventional clinical study. The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quad MRI SureScan LV lead (Model 4798). 

All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an Attain Stability Quad MRI SureScan LV Lead (Model 4798). Subjects will complete visits at enrollment/baseline, implant, 3 months, 6 months, and then every 6 months thereafter

Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted across up to 56 sites worldwide.

SPONSOR: Medtronic, Inc.

Principal Investigator: Dr. Ostrom

Sub-Investigators:  Dr. Ji, Dr. Kosar, Dr. Kim

Current Study Status:  Enrollment closed, Study closed

Link to clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT03099655?term=NCT03099655&rank=1

 

ARMS REGISTRY

This is a registry to evaluate the procedural and short term safety of a percutaneous upper extremity access for mechanical circulatory support devices such as, intra-aortic balloon pumps (IABPs) and the Impella family of ventricular assist devices. The registry will collect data on physician implantation technique and in-hospital patient outcomes.

The registry will close after 100 axillary impella implant data has been collected.

SPONSOR: James McCabe, M.D at University of Washington Medical Center

Principal Investigator: Dr. Wyman

Current Study Status:  Enrollment closed, Study closed

 

ECLIPSE

Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug Eluting Stents 

This is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with Orbital Atherectomy (OA)  using the Diamondback 360® Coronary Orbital Atherectomy System (OAS) 1.25mm classic crown compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions. 

All subjects will be followed post-procedure to discharge; at 30-day; 90-day; at 1-year; and at 2-years post index procedure. Approximately 2000 subjects will be enrolled across approximately 60 US sites. 

SPONSOR: CSI (Cardiovascular Systems, Inc.)

Principal Investigator: Dr. Wyman

Sub-Investigators:  Dr. Chhabra, Dr. Matchison, Dr. Azam 

Current Study Status:  Enrollment closed, Study closed

Link to clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03108456?cond=eclipse&rank=4

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