Monomorphic Ventricular Tachycardia
Conditions
Keywords
Monomorphic Ventricular Tachycardia, Ischemic, Non-ischemic, Catheter Ablation
Brief summary
To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia \[MMVT\] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.
Detailed description
Approximately 50 centers in the United States (US) will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.
Interventions
DEVICECardiac catheter ablation with ICD/CRT-D
Cardiac ablation catheter system
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible. * Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)\*\* by one or more of the following: Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study * 18 to 75 years of age * Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board. * Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not.
Exclusion criteria
* Any history of stroke * S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment * Patient is pregnant or nursing * Patient has New York Heart Association (NYHA) class IV heart failure * Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥3) hours) * Patient has VT/VF thought to be from channelopathies * Limited life expectancy (less than one year) according to Investigator * Patient has current class IV angina * Recent coronary artery bypass graft (CABG \< 60 days) or percutaneous coronary intervention (PCI \< 30 days) * Patient is currently participating in another investigational drug or device study * Patient is unable or unwilling to cooperate with the study procedures * Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram (TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS \> 1 * Prosthetic mitral or aortic valve * Mitral or aortic valvular heart disease requiring immediate surgical intervention * Major contraindication to anticoagulation therapy or coagulation disorder * Left Ventricular Ejection Fraction \< 15% * Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (\> 3 months) outflow tract tachycardia * Patient has glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 within the past 3 months * Patient has peripheral vascular disease that precludes LV access * Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD * Patient has reversible cause of VT * Use of left ventricular assist device (LVAD) or Tandem Heart devices (Impella and Balloon pumps are acceptable) * There is a strong clinical reason to believe that, in the opinion of the investigator, the patient only has septal scar that is deep
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Experienced an ICD Shock Event. | 12 months | Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up |
| Number of Subjects Who Experienced a Select Serious Adverse Event | 30 days | Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit | 12 months | Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up. |
Countries
Australia, France, Italy, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Subjects-Ablation | 11 |
| Randomized Subjects-Control | 8 |
| Registry Subjects | 26 |
| Early Withdrawal Subjects | 19 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not receive treatment | 4 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Randomized Subjects-Ablation | Randomized Subjects-Control | Registry Subjects | Early Withdrawal Subjects | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 5.9 | 61.3 years STANDARD_DEVIATION 7.3 | 60.6 years STANDARD_DEVIATION 10.8 | 58.4 years STANDARD_DEVIATION 15 | 60.9 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 5 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 9 Participants | 6 Participants | 21 Participants | 13 Participants | 49 Participants |
| Region of Enrollment France | 4 participants | 2 participants | 0 participants | 1 participants | 7 participants |
| Region of Enrollment Italy | 1 participants | 0 participants | 5 participants | 1 participants | 7 participants |
| Region of Enrollment United States | 6 participants | 6 participants | 21 participants | 17 participants | 50 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 6 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 20 Participants | 15 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 64 | 0 / 11 | 0 / 8 | 1 / 26 | 0 / 19 |
| other Total, other adverse events | 4 / 64 | 1 / 11 | 2 / 8 | 1 / 26 | 0 / 19 |
| serious Total, serious adverse events | 9 / 64 | 5 / 11 | 2 / 8 | 2 / 26 | 0 / 19 |
Outcome results
Primary
Number of Subjects Who Experienced an ICD Shock Event.
Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Subjects-Ablation | Number of Subjects Who Experienced an ICD Shock Event. | 1 Participants |
| Randomized Subjects- Control | Number of Subjects Who Experienced an ICD Shock Event. | 1 Participants |
| Registry Subjects | Number of Subjects Who Experienced an ICD Shock Event. | 0 Participants |
| Early WIthdrawal Subjects | Number of Subjects Who Experienced an ICD Shock Event. | NA Participants |
Primary
Number of Subjects Who Experienced a Select Serious Adverse Event
Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.
Time frame: 30 days
Population: 4 subjects randomized to treatment arm but did not receive ablation (not treated) and therefore excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Subjects-Ablation | Number of Subjects Who Experienced a Select Serious Adverse Event | 2 Participants |
| Randomized Subjects- Control | Number of Subjects Who Experienced a Select Serious Adverse Event | NA Participants |
| Registry Subjects | Number of Subjects Who Experienced a Select Serious Adverse Event | NA Participants |
| Early WIthdrawal Subjects | Number of Subjects Who Experienced a Select Serious Adverse Event | NA Participants |
Secondary
Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Subjects-Ablation | Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit | 3 Participants |
| Randomized Subjects- Control | Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit | 1 Participants |
| Registry Subjects | Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit | 2 Participants |
| Early WIthdrawal Subjects | Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit | 0 Participants |