Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
Shock prevention, Single vs. Dual Chamber, Reduce ventricular pacing, Atrial Fibrillation, Remote Monitoring, ICD, Implantable Cardioverter Defibrillator
Brief summary
The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death
Detailed description
While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for sudden death prevention in high risk individuals, reduction of device associated morbidity remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown modest benefits of atrial pacing in preventing atrial fibrillation, however right ventricular (RV) pacing was not limited, thus any favorable effects associated with atrial prevention and treatment may have been offset by the RV pacing. New algorithms to prevent RV pacing are now made available in our current devices. The choice of dual chamber versus single chamber ICD for primary prevention warrants re-assessment of atrial prevention and termination therapies, without the potentially adverse effects of RV pacing. This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50 to dual chamber ICDs. Patients will be followed for one year.
Interventions
DEVICEDual Chamber ICD
Dual Chamber ICD: Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation Dual Chamber ICD Atrial prevention and termination therapies, Managed Ventricular Pacing (MVP)along with VT/VF detection and therapies for dual chamber device.
DEVICESingle Chamber ICD
Single Chamber: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. VT/VF detection and therapies with discrimination criteria for single chamber device.
Sponsors
Medtronic
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Candidates for ICD for primary prevention according to American Heart Association/American College of Cardiology (AHA/ACC) guidelines who have a clinical indication for ICD implantation for ventricular arrhythmia or sudden death prevention. * The ability to understand the scope of the study, provide written informed consent, and a willingness to complete all study visits and associated procedures.
Exclusion criteria
* Pregnant women * Age \<18 years old * Inability to provide consent * On a heart transplant waiting list * Life expectancy \<1 year * Indication for pacing * Atrioventricular (AV) node ablation * Permanent atrial fibrillation or atrial flutter * Indication for cardiac resynchronization * Preexisting, separate pacemaker pulse generator that won't be explanted * Intra-aortic balloon pump or other device * Inotropic drug (not digitalis) necessary for hemodynamic support * Chronic serious bacterial infection * Inability to receive pectoral non-thoracotomy lead ICD * Inability to program device according to protocol * History of Out of Hospital Cardiac Arrest (OHCA) or sustained Ventricular Tachycardia as an indication for ICD (secondary prevention indication)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) | Baseline to 12 months after ICD implantation | An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes | Baseline to 12 Months | Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes. |
| Number of Appropriate Shocks by ICD | Baseline to 12 Months | Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm. |
| Total Cost of ICD Implantation Procedure | Baseline | — |
| Number of Subjects With Newly Detected Atrial Tachyarrhythmias | Baseline to 12 months after ICD implantation | — |
| Atrial Fibrillation (AF) Burden | Implantation through 1 year | AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value. |
Countries
Israel, United States
Participant flow
Recruitment details
From 2008 to 2010, patients who were undergoing Implantable Cardioverter-Defibrillators (ICD) device implantation at Mayo Clinic in Rochester, Minnesota and Jacksonville, Florida and at two Israeli medical center sites, Sheba Medical Center in Ramat Gan and Carmel Medical Center in Haifa, were screened for entry into this open-label study.
Participants by arm
| Arm | Count |
|---|---|
| Dual Chamber ICD Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation. | 50 |
| Single Chamber ICD Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Single Chamber ICD | Dual Chamber ICD | Total |
|---|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 14.8 | 62.6 years STANDARD_DEVIATION 12.4 | 61.2 years STANDARD_DEVIATION 13.7 |
| Cardiac Disease Coronary Artery Bypass Graft | 20 Participants | 16 Participants | 36 Participants |
| Cardiac Disease Coronary Artery Disease | 36 Participants | 35 Participants | 71 Participants |
| Cardiac Disease Dilated Cardiomyopathy | 10 Participants | 13 Participants | 23 Participants |
| Cardiac Disease Hypertrophic Cardiomyopathy | 6 Participants | 6 Participants | 12 Participants |
| Cardiac Disease Myocardial Infarction | 35 Participants | 31 Participants | 66 Participants |
| Cardiac Disease Percutaneous Coronary Intervention | 27 Participants | 23 Participants | 50 Participants |
| Co-morbidities Diabetes | 18 participants | 15 participants | 33 participants |
| Co-morbidities History of Paroxysmal Atrial Fibrillation | 3 participants | 6 participants | 9 participants |
| Co-morbidities Hyperlipidemia | 36 participants | 34 participants | 70 participants |
| Co-morbidities Hypertension | 26 participants | 32 participants | 58 participants |
| Co-morbidities Pulmonary Disease | 7 participants | 1 participants | 8 participants |
| Co-morbidities Stroke | 3 participants | 2 participants | 5 participants |
| Co-morbidities Transient Ischemic Attack | 3 participants | 0 participants | 3 participants |
| Concomitant Medications Amiodarone | 3 Participants | 1 Participants | 4 Participants |
| Concomitant Medications Beta Blocker | 44 Participants | 47 Participants | 91 Participants |
| Concomitant Medications Calcium Channel Blocker | 3 Participants | 2 Participants | 5 Participants |
| LV Ejection Fraction | 29.6 Percentage of LV blood volume STANDARD_DEVIATION 13.3 | 30.1 Percentage of LV blood volume STANDARD_DEVIATION 14.1 | 29.9 Percentage of LV blood volume STANDARD_DEVIATION 13.7 |
| NYHA Classification Heart Failure present but NYHA class not recorded | 1 Participants | 2 Participants | 3 Participants |
| NYHA Classification III-Limitation with less than daily activity | 10 Participants | 8 Participants | 18 Participants |
| NYHA Classification II- Limitation with ordinary activity | 23 Participants | 24 Participants | 47 Participants |
| NYHA Classification I- No limitation | 11 Participants | 8 Participants | 19 Participants |
| NYHA Classification IV-Symptoms at rest | 0 Participants | 1 Participants | 1 Participants |
| NYHA Classification NA-No heart failure | 5 Participants | 7 Participants | 12 Participants |
| Region of Enrollment Israel | 25 participants | 25 participants | 50 participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 41 Participants | 42 Participants | 83 Participants |
| Ventricular Depolarization (QRS) Duration | 103.9 milliseconds STANDARD_DEVIATION 18.2 | 112.1 milliseconds STANDARD_DEVIATION 26.3 | 108.4 milliseconds STANDARD_DEVIATION 23.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 50 | 5 / 50 |
| serious Total, serious adverse events | 8 / 50 | 8 / 50 |
Outcome results
Primary
Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)
An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).
Time frame: Baseline to 12 months after ICD implantation
Population: Intent to Treat population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dual Chamber ICD | Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) | 1 Participants |
| Single Chamber ICD | Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) | 1 Participants |
p-value: 1Log Rank
Secondary
Atrial Fibrillation (AF) Burden
AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.
Time frame: Implantation through 1 year
Population: Intent to treat analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Chamber ICD | Atrial Fibrillation (AF) Burden | 0.02 Percentage of atrial arrhythmias per min | Standard Deviation 0.07 |
| Single Chamber ICD | Atrial Fibrillation (AF) Burden | 0 Percentage of atrial arrhythmias per min | Standard Deviation 0 |
Secondary
Number of Appropriate Shocks by ICD
Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
Time frame: Baseline to 12 Months
Population: Intent to Treat population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dual Chamber ICD | Number of Appropriate Shocks by ICD | 31 Shocks |
| Single Chamber ICD | Number of Appropriate Shocks by ICD | 1 Shocks |
p-value: 0.05t-test, 2 sided
Secondary
Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes
Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.
Time frame: Baseline to 12 Months
Population: Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dual Chamber ICD | Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes | 37 Episodes |
| Single Chamber ICD | Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes | 0 Episodes |
Secondary
Number of Subjects With Newly Detected Atrial Tachyarrhythmias
Time frame: Baseline to 12 months after ICD implantation
Population: Intent to Treat population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dual Chamber ICD | Number of Subjects With Newly Detected Atrial Tachyarrhythmias | 12 Participants |
| Single Chamber ICD | Number of Subjects With Newly Detected Atrial Tachyarrhythmias | 0 Participants |
p-value: <0.001t-test, 2 sided
Secondary
Total Cost of ICD Implantation Procedure
Time frame: Baseline
Population: Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dual Chamber ICD | Total Cost of ICD Implantation Procedure | 16,579 US Dollars |
| Single Chamber ICD | Total Cost of ICD Implantation Procedure | 14,249 US Dollars |