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Trial record 78 of 132 for:    "Paroxysmal Ventricular Fibrillation"

The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock (RAPTURE)

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ClinicalTrials.gov Identifier: NCT00787800
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : June 11, 2014
Last Update Posted : July 24, 2014
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Paul A. Friedman, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ventricular Tachycardia
Ventricular Fibrillation
Atrial Fibrillation
Supraventricular Tachycardia
Interventions Device: Dual Chamber ICD
Device: Single Chamber ICD
Enrollment 100
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.
Pre-assignment Details  
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation. Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
Period Title: Overall Study
Started 50 50
Completed 47 43
Not Completed 3 7
Reason Not Completed
Withdrawal by Subject             3             5
Death             0             2
Arm/Group Title Dual Chamber ICD Single Chamber ICD Total
Hide Arm/Group Description 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. Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
62.6  (12.4) 59.9  (14.8) 61.2  (13.7)
[1]
Measure Description: Date of birth not obtained for 4 Israeli subjects (treatment arm unknown).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
8
  16.0%
9
  18.0%
17
  17.0%
Male
42
  84.0%
41
  82.0%
83
  83.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
United States 25 25 50
Israel 25 25 50
NYHA Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
I- No limitation 8 11 19
II- Limitation with ordinary activity 24 23 47
III-Limitation with less than daily activity 8 10 18
IV-Symptoms at rest 1 0 1
NA-No heart failure 7 5 12
Heart Failure present but NYHA class not recorded 2 1 3
[1]
Measure Description:

New York Heart Association (NYHA) classification of Heart Failure is used to describe the degree of limitation due to heart failure at baseline.

I. No limitation, II. Limitation with ordinary activity, III. Limitation with less than daily activity, IV. Symptoms at rest, (NA-Not applicable; participants without heart failure)

LV Ejection Fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of LV blood volume
Number Analyzed 50 participants 50 participants 100 participants
30.1  (14.1) 29.6  (13.3) 29.9  (13.7)
[1]
Measure Description: Left ventricular Ejection Fraction (LVEF) is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a calculated measure of the amount of blood pumped out of the lower chamber of the heart during a heartbeat, measured using echocardiography. A normal LVEF ranges from 55-70%. A LVEF of 65, for example, means that 65% of the total amount of blood in the left ventricle is pumped out with each heartbeat. Note: LVEF baseline data is missing for one Israeli subject, arm unknown.
Co-morbidities   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Pulmonary Disease 1 7 8
Diabetes 15 18 33
Hypertension 32 26 58
Hyperlipidemia 34 36 70
Stroke 2 3 5
Transient Ischemic Attack 0 3 3
History of Paroxysmal Atrial Fibrillation 6 3 9
[1]
Measure Description: Participants could have had more than one co-morbidity, therefore the sum total of co-morbid conditions will not equal the total number of participants.
Cardiac Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Coronary Artery Disease 35 36 71
Myocardial Infarction 31 35 66
Percutaneous Coronary Intervention 23 27 50
Coronary Artery Bypass Graft 16 20 36
Hypertrophic Cardiomyopathy 6 6 12
Dilated Cardiomyopathy 13 10 23
[1]
Measure Description: Participants could have more than one concomitant cardiac disease event/diagnosis, therefore the sum total of all cardiac conditions will not equal the total number of participants.
Concomitant Medications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Beta Blocker 47 44 91
Calcium Channel Blocker 2 3 5
Amiodarone 1 3 4
[1]
Measure Description: Each category lists the number of participants taking each medication.
Ventricular Depolarization (QRS) Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliseconds
Number Analyzed 50 participants 50 participants 100 participants
112.1  (26.3) 103.9  (18.2) 108.4  (23.1)
[1]
Measure Description: Note:QRS baseline data is missing for one Israeli subject. As the heart undergoes depolarization and repolarization, the electrical currents that are generated spread within the heart & throughout the body. This electrical activity can be measured by electrodes placed on the body surface & produce a tracing called an electrocardiogram (ECG, or EKG). The different waves that comprise the ECG represent the sequence of depolarization and repolarization of the atria and ventricles. Certain points on the ECG tracing are assigned letters. The QRS complex represents ventricular depolarization.
1.Primary Outcome
Title Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population analyzed.
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description:
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.
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Participants
1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dual Chamber ICD, Single Chamber ICD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description:
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.
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Episodes
37 0
3.Secondary Outcome
Title Number of Appropriate Shocks by ICD
Hide Description Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
Time Frame Baseline to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population analyzed.
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description:
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.
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Shocks
31 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dual Chamber ICD, Single Chamber ICD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Total Cost of ICD Implantation Procedure
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description:
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.
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: US Dollars
16,579  (1,359) 14,249  (1,421)
5.Secondary Outcome
Title Number of Subjects With Newly Detected Atrial Tachyarrhythmias
Hide Description [Not Specified]
Time Frame Baseline to 12 months after ICD implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population analyzed.
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description:
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.
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Participants
12 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dual Chamber ICD, Single Chamber ICD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Atrial Fibrillation (AF) Burden
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population.
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description:
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.
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: Percentage of atrial arrhythmias per min
0.02  (0.07) 0  (0)
Time Frame Implantation of ICD to one year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dual Chamber ICD Single Chamber ICD
Hide Arm/Group Description 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. Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
All-Cause Mortality
Dual Chamber ICD Single Chamber ICD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dual Chamber ICD Single Chamber ICD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/50 (16.00%)      8/50 (16.00%)    
Cardiac disorders     
Atrial Fibrillation   1/50 (2.00%)  1 0/50 (0.00%)  0
Fluid overload   0/50 (0.00%)  0 1/50 (2.00%)  1
High Blood Pressure   0/50 (0.00%)  0 1/50 (2.00%)  1
Palpitations   1/50 (2.00%)  2 0/50 (0.00%)  0
Syncope   1/50 (2.00%)  1 0/50 (0.00%)  0
General disorders     
Death * [1]  0/50 (0.00%)  0 2/50 (4.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer spreading   1/50 (2.00%)  1 0/50 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chest Pain   0/50 (0.00%)  0 2/50 (4.00%)  2
Difficulty Breathing   1/50 (2.00%)  1 1/50 (2.00%)  1
Dyspnea   1/50 (2.00%)  1 0/50 (0.00%)  0
Surgical and medical procedures     
Defibrillator Threshold testing could not be done at implant   1/50 (2.00%)  1 0/50 (0.00%)  0
Right ventricular lead replaced   1/50 (2.00%)  1 0/50 (0.00%)  0
Vascular disorders     
Venous thromboembolism   0/50 (0.00%)  0 1/50 (2.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
The cause of death for two Israeli subjects was not reported.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dual Chamber ICD Single Chamber ICD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/50 (32.00%)      5/50 (10.00%)    
Cardiac disorders     
Pericarditis   1/50 (2.00%)  1 1/50 (2.00%)  1
Infections and infestations     
Infection/Erosion   1/50 (2.00%)  1 1/50 (2.00%)  1
Injury, poisoning and procedural complications     
Device dislodgement from ventricle   1/50 (2.00%)  1 1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumothorax/Hemothorax   0/50 (0.00%)  0 1/50 (2.00%)  1
Surgical and medical procedures     
Device Oversensing-Atrial   4/50 (8.00%)  5 0/50 (0.00%)  0
Device Oversensing-Ventricle   3/50 (6.00%)  3 1/50 (2.00%)  1
Device Failure to Capture-Atrial   2/50 (4.00%)  2 0/50 (0.00%)  0
Vascular disorders     
Hematoma/Seroma   2/50 (4.00%)  2 0/50 (0.00%)  0
Phlebitis/Thrombosis/Embolism   1/50 (2.00%)  1 0/50 (0.00%)  0
Cerebrovascular Accident/Transient Ischemic Attack   1/50 (2.00%)  1 0/50 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul A. Friedman, MD, Professor of Medicine
Organization: Mayo Clinic
Phone: 507-284-7661
Publications:
Responsible Party: Paul A. Friedman, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00787800     History of Changes
Other Study ID Numbers: 08-003618
First Submitted: November 6, 2008
First Posted: November 10, 2008
Results First Submitted: May 21, 2013
Results First Posted: June 11, 2014
Last Update Posted: July 24, 2014