Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
- Conditions
- Heart Failure
- Interventions
- Device: WiSE System
- Registration Number
- NCT02922036
- Lead Sponsor
- EBR Systems, Inc.
- Brief Summary
This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
- Detailed Description
The WiSE-CRT System is an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment WiSE System WiSE System therapy ON with Guideline Directed Medical Therapy
- Primary Outcome Measures
Name Time Method Primary Efficacy 1 6 Months Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.
Primary Safety 6 Months Freedom from Procedure and Device System related Type 1 Complications
- Secondary Outcome Measures
Name Time Method Secondary Efficacy 2 6 Months Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from pre-discharge through the 6-month follow-up post-implant visit
Secondary Efficacy 5 6 months KCCQ responder analysis for ≥ 5 points absolute increase from baseline to 6 months
Secondary Efficacy 3 6 months % Bi-ventricular pacing at 6 months
Secondary Efficacy 1 6 Months Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit
Secondary Efficacy 4 6 months EF responder analysis for ≥ 5% absolute increase from baseline to 6 months.
Trial Locations
- Locations (68)
Emory Healthcare
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Heart Center Research
🇺🇸Huntsville, Alabama, United States
Prairie Heart
🇺🇸Springfield, Illinois, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Ochsner Medical Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Saint Luke's Health System Kansas City
🇺🇸Kansas City, Kansas, United States
Michigan Heart
🇺🇸Canton, Michigan, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
United Heart and Vascular Clinic
🇺🇸Saint Paul, Minnesota, United States
AtlantiCare Regional Medical Center
🇺🇸Pomona, New Jersey, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
PeaceHealth
🇺🇸Springfield, Oregon, United States
UPMC Heart and Vascular Institute
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Penn State Health, Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sentara Healthcare
🇺🇸Norfolk, Virginia, United States
Sydney Adventist Hospital
🇦🇺Wahroonga, New South Wales, Australia
Canberra Hospital
🇦🇺Garran, Canberra, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
CHU Grenoble - Hopital Michallon Service de Cardiologie
🇫🇷Grenoble, France
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom
Fiona Stanley Hospital
🇦🇺Perth, Western Australia, Australia
Isala Hartcentrum
🇳🇱Zwolle, Netherlands
Policlinico S. Orsola
🇮🇹Bologna, Italy
Ospedale San Gerardo
🇮🇹Monza, Italy
CHU-Hopital Pontchaillou
🇫🇷Rennes, France
Barts Heart Centre
🇬🇧London, United Kingdom
Manchester Heart Centre
🇬🇧Manchester, United Kingdom
St. Thomas Hospital
🇬🇧London, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Methodist Physicians Clinic Heart Consultants
🇺🇸Omaha, Nebraska, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Immanuel Klinikum Bernau - Herzzentrum Brandenburg
🇩🇪Bernau, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)
🇩🇪Hamburg, Germany
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Naples Community Hospital
🇺🇸Naples, Florida, United States
St. Vincent's Hospital and Healthcare Center
🇺🇸Indianapolis, Indiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
St. Vincent's Healthcare
🇺🇸Jacksonville, Florida, United States
Northside Hospital and Heart Institute
🇺🇸Saint Petersburg, Florida, United States
William Beaumont Hospital
🇺🇸Hazel Park, Michigan, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Houston Methodist
🇺🇸Sugar Land, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, Australia
Centre Cardiologique du Nord
🇫🇷Paris, France
Stern Cardiovascular Center
🇺🇸Germantown, Tennessee, United States
Royal Melbourne Hospital / Royal Hobart Hospital
🇦🇺Parkville, Victoria, Australia
Monash Heart
🇦🇺Clayton, Victoria, Australia
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
MUSC Gazes Research Institute
🇺🇸Charleston, South Carolina, United States