Research-Test
At Cardiovascular Specialists of New England’s Research Foundation, our mission is to engage in ethical, innovative, and impactful research to advance the treatment of cardiovascular disease. We work collaboratively with industry leaders to shape the future of cardiovascular care through evidence-based clinical trials. We strive to utilize our findings in these high-quality research studies to transform treatment and outcomes for all cardiovascular patients.
RHAPSODY: Rhythmia Mapping and Signal Acquisition for Data Analysis
The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this study will be used to guide development and refinement of new software features that may be implemented in future commercial software releases.
Sponsor: Boston Scientific Corporation
Principal Investigator: Jamie Kim, MD
INTERVENTION/TREATMENT
This study will evaluate the performance of potential next-generation software features in a low-risk clinical environment by streaming raw signals from a commercial Rhythmia Workstation during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial fibrillation, atrial tachycardias, and ventricular tachycardia. The data will be evaluated on a parallel investigational Rhythmia Workstation using prototype software features. These next-generation software features and algorithms will not be available to the physician during the case and will therefore have no diagnostic or therapeutic impact on the clinical case.
ELIGIBILITY CRITERIA
Scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.
ClinicalTrials.gov ID NCT03053141
CHAMPION-AF: WATCHMAN FLX Versus NOAC for Embolic Protection in in the Management of Patients With Non-Valvular Atrial Fibrillation
The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.
Sponsor: Boston Scientific Corporation
Principal Investigator: Jamie Kim, MD
INTERVENTION/TREATMENT
This study is a prospective, randomized, multi-center global investigation. Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device (“Device Group”) or a commercially available non-vitamin K oral anticoagulant (“Control Group”).
ELIGIBILITY CRITERIA
The subject has a calculated CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score of 2 or greater for men and 3 or greater for women
ClinicalTrials.gov ID NCT04394546
AVANT GUARD: Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.
Sponsor: Boston Scientific Corporation
Principal Investigator: Jamie Kim, MD
INTERVENTION/TREATMENT
This is a prospective, randomized, multi-center, global, pivotal Investigational device exemption (IDE) study. Subjects with persistent atrial fibrillation will be randomized or assigned to either pulsed field ablation (PFA) or Versus Anti-Arrhythmic Drug (AAD) treatment.
ELIGIBILITY CRITERIA
Have symptomatic persistent atrial fibrillation, confirmed by both:
- Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either:
- A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR
- Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart
- Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days
ClinicalTrials.gov ID NCT06096337
Conformal Early Feasibility Study: An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
Sponsor: Conformal Medical, Inc.
Principal Investigator: Jamie Kim, MD
INTERVENTION/TREATMENT
The Conformal Left Atrial Appendage Seal (CLAAS) Device is a permanent implant designed to occlude the left atrial appendage (LAA) to eliminate blood flow into and clot passage from the LAA.
ELIGIBIILTY CRITIERIA
Male or non-pregnant female aged ≥18 years
Documented non-valvular AF (paroxysmal, persistent, or permanent)
High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women
ClinicalTrials.gov ID NCT03616028
The CONFORM Pivotal Trial: An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion
The CLAAS® (Conformal Left Atrial Appendage Seal) device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation.
Sponsor: Conformal Medical, Inc
Principal Investigator: Jamie Kim, MD
INTERVENTION/TREATMENT
Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.
ELIGIBILITY CRITIERIA
Documented non-valvular AF (paroxysmal, persistent, or permanent)
High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
ClinicalTrials.gov ID NCT05147792
RESTORE: Redo Transcatheter Aortic Valve Replacement for Transcatheter Aortic Valve Failure
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Sponsor: Medtronic, Inc
Principal Investigator: Fahad Gilani, MD
INTERVENTION/TREATMENT
Medtronic Transcatheter Aortic Valve, or
Edwards Transcatheter Aortic Valve
ELIGIBILITY CRITIERIA
Bioprosthetic Valve Failure (BVF) of a transcatheter aortic valve (TAV) (either Medtronic or Edwards) requiring redo TAVR
ClinicalTrials.gov ID NCT06777368
Evolut EXPAND TAVR II Pivotal Trial
The objective of this clinical trial is to obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate aortic stenosis.
Sponsor: Medtronic, Inc
Principal Investigator: Fahad Gilani, MD
INTERVENTION/TREATMENT
Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.
ELIGIBILITY CRITIERIA
Moderate aortic stenosis defined by transthoracic echo
Elevated aortic valve calcium score
Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
ClinicalTrials.gov ID NCT05149755
PARADIGM: A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for TAVR, will be enrolled in the ‘All Comers Randomized Cohort’.
Sponsor: Anteris Technologies, Ltd
Principal Investigator: Fahad Gilani, MD
INTERVENTION/TREATMENT
Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved THV from the SAPIEN series or the Evolut series and followed for 10 years.
ELIGIBILITY CRITIERIA
The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
ClinicalTrials.gov ID NCT07194265
EMPOWER CAD: Equity in Modifying Plaque Of Women With Undertreated Calcified Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary Intravascular Lithotripsy (IVL) in a population of female subjects with calcified coronary artery disease.
Sponsor: Shockwave Medical, Inc
Principal Investigator: Xiaoyu (Sylvia) Yang-Giuliano, MD
INTERVENTION/TREATMENT
Up to 400 female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care. Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.
ELIGILIBITY CRITIERIA
The subject is a non-pregnant female ≥18 years of age
The subject meets indications for PCI and stent
The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
ClinicalTrials.gov ID NCT05755711
SELUTION4ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.
Sponsor: M.A. Med Alliance S.A.
Principal Investigator: Stephan Heo, MD
INTERVENTION/TREATMENT
Subjects with previous bare-metal stent (BMS) or DES (Drug-Eluting Stent) and qualifying evidence for ISR (In-stent Restenosis) will be randomized 1:1 to treatment with either the SELUTION SLR 014 DEB (Drug-Eluting Balloon) or standard of care treatment
ELIGIBILITY CRITIERIA
Subject presents with chronic coronary syndrome (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST-elevation myocardial infarction, biomarkers stabilized or down trending with an indication for percutaneous coronary intervention.
ClinicalTrials.gov ID NCT04280029
PROTECT IV: Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Sponsor: Abiomed, Inc
Principal Investigator: Stephan Heo, MD
INTERVENTION/TREATMENT
Impella CP / Impella CP with SmartAssist will be used in most patients randomized to the Impella arm. Impella 2.5 may be used in patients with small body size (BMI <20 kg/m2 or body weight <60 kg) or if the iliofemoral vasculature is able to accommodate the smaller Impella 2.5 device but not the Impella CP device.
ELIGIBITY CRITIERIA
Subject has CCS (Chronic Coronary Syndrome) or NSTEMI with an LVEF ≤40%
Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30%
ClinicalTrials.gov ID NCT04763200
Source: Clinical research trial information referenced in this web page was derived from ClinicalTrials.gov.