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JAVA CRT-D


Title Junctional AV Ablation in CRT-D Patients with Atrial Fibrillation
Therapeutic Area Atrial Fibrillation, Cardiac Arrhythmia
Principal Investigator Christopher Madias, MD
Min Age 21 Years
Gender All
Contact Melanie Marshall, RN
617-636-1144
More Information https://www.clinicaltrials.gov/ct2/show/NCT02946853

Overview

The primary aim of the study is to determine if patients with permanent AF who meet conventional criteria for CRT and undergo AVJ ablation have reduced ventricular remodeling (i.e. echocardardiographic improvement of LV end systolic volume), a potent marker of subsequent clinical deterioration, compared to patients who do not undergo AVJ ablation. This study is designed to test feasibility of enrollment and short-term improvement in surrogate endpoints, with anticipation of a full-scale large randomized clinical trial using hard outcome events if this phase is promising. 

Study Details

Inclusion Criteria

  • Persistent Atrial Fibrillation for > 6 months
  • Resting Ventricular Rate < 90bpm, > 50bpm
  • NYHA Class II-IV

Exclusion Criteria

  • Severe Aortic or Mitral Valve Disease and/or valvular repair procedures
  • Acute coronary syndrome, MI, CABG, PCI, or required revascularization
  • Prior AF ablation procedure

Study Requirements

  1. Screening Visit: Informed Consent, Eligibility Confirmation (15 minutes)
  2. Randomization Visit (Within 1 month): Medical History, Medications, Symptom Assessment, Quality of Life Questionnaire, 12-lead ECG (S.O.C.), Echocardiogram (S.O.C.). (45 minutes)
  3. CRT-D and possible ablation (Within 1 month of randomization): CRT-D implantation, CRT-D Programming, AVJ ablation (if randomized into ablation arm), device programming. (5 hours)
  4. Follow Up 1 (Within 1 month of randomization): Symptom assessment, physical exam, 12-lead ECG (SOC), device check (SOC). (30 minutes)
  5. Follow Up 2 (Within 3 months of randomization): Symptom assessment, physical exam, 12-lead ECG (SOC), Device Check (SOC). (30 minutes)
  6. Follow Up 3 (within 6 months of randomization): Physical Exam, Symptom assessment, quality of life survey, 12-lead ECG (SOC), Echocardiogram (SOC), Device check (SOC). (30 minutes)