NHKI - Procedural interventions

Ongoing Studies

• Bariatric surgery

  BRAVE

  • Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial
  • Obesity is common in people with heart disease and increases the risk of complications. The BRAVE study aims to determine if weight-loss (metabolic) surgery can safely reduce these risks in individuals with obesity and high-risk heart disease. Sub-studies will also assess the effects of bariatric surgery on quality of life, mental health, and healthcare costs.
• Cardiac pacing

  LEFT-HF

  • LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure
  • Patients with heart block often rely on pacemakers to regulate their heart’s electrical signals. However, those completely dependent on pacemakers may develop pacing-induced cardiomyopathy, a weakening of the heart muscle that can lead to heart failure. This study compares a novel pacemaker placement approach, left bundle branch pacing, to standard right ventricular pacing to assess the risk of pacing-induced cardiomyopathy and heart failure.
• Left atrial appendage occlusion

  LAAOS-4

  • The Fourth Left Atrial Appendage Occlusion Study
  • Atrial fibrillation is a common condition where the heart’s upper chambers beat too fast and irregularly, reducing pumping efficiency. This can cause blood to pool in the left atrial appendage, increasing the risk of clot formation. If a clot enters the bloodstream, it can block arteries and cause a stroke. Atrial fibrillation raises stroke risk by 3–5 times.
  • The LAAOS-4 study aims to determine if closing the left atrial appendage with the WATCHMAN FLX™ or FLX PRO™ device, along with Oral Anticoagulant (OAC) medication, is more effective at preventing strokes and blood clots than OAC medication alone.

Studies Closed for Recruitment, Patients in Follow-Up

• Coronary interventions

  COMBINE-Intervene

  • COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
  • 14 participants enrolled

  COMPLETE-2

  • A randomized trial of physiology-guided versus angiography-guided nonculprit lesion (NCL) complete revascularization strategies
  • 41 participants enrolled
• Radiation therapy

  MA.39 (TAILOR RT)

  • TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer
  • 9 participants enrolled
  • PACE
  • PACE: International Randomised Study of Prostatectomy vs. Stereotactic Bosy Radiotherapy (SBRT) and Conventional Radiotherapy vs. SBRT for Early-Stage Organ-Confined Prostate Cancer
  • 9 participants enrolled

  PBS

  • PBS: Prostate Boost Irradiation with Stereotactic Body RT (SBRT).  A randomized phase II trial investigating Stereotactic Body Radiotherapy (SBRT) for prostate boost irradiation in the treatment of high-risk prostate cancer
  • 54 participants enrolled

  SABR-COMET-3

  • SABR-COMET-3: Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer
  • 22 participants enrolled

  SABR-COMET-10

  • SABR-COMET-10: Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors
  • 9 participants enrolled

Completed Studies

• Coronary interventions

  HD-PCI

  • Higher vs. Lower Dose Heparin for PCI
  • 486 participants enrolled

  UNIVERSAL

  • Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial
  • 44 participants enrolled
• Radiation therapy

  AROW

  • AROW: Accelerated Radiotherapy Outcomes in Women (Long Term Outcomes of a Randomized Trial of Breast Irradiation Schedules After Lumpectomy in Women With Node-Negative Breast Cancer)
  • 85 participants enrolled

  BR.6

  • BR.6: A Clinical Trial of Early Versus Late Radiotherapy for Treatment of Limited Small Cell Carcinoma of the Lung
  • 5 participants enrolled

  BR.8

  • BR.8: A Randomized Phase III Study of CODE Plus Thoracic Irradiation Versus Alternating CAV and EP for Extensive Stage Small Cell Lung Cancer
  • 3 participants enrolled

  BR.9

  • BR.9: A Phase III Prospective Randomized Study of Combination Chemotherapy and Surgery Versus Radiotherapy for Stage IIIA Non-Small Cell Lung Cancer
  • 2 participants enrolled

  LUSTRE

  • LUSTRE: A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
  • 2 participants enrolled

  NCT00002550

  • NCT00002550:  A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection for Stage IIIA (N2) Non-Small Cell Lung Cancer
  • 2 participants enrolled

  NCT00003422

  • NCT00003422: Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed

  NCT00005957

  • NCT00005957: Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer

  NCT00052910

  • NCT00052910: Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
  • 1 participant enrolled

  NCT00156052

  • NCT00156052: Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

  RAPID

  • RAPID:  Randomized Trial of Accelerated Partial Breast Irradiation
  • 36 participants enrolled