VT-CoA: Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00412607
• Collaborator: (none)
• Enrollment: 249
• Locations: 18
• Arm: 1
• Duration (Months): 65
• Patients Per Site: 13.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Device: NAVISTAR® THERMOCOOL® Catheter	Phase 4

Detailed Description

This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with ischemic ventricular tachycardia will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 249 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NaviStar ThermoCool Catheter	Device: NAVISTAR® THERMOCOOL® Catheter; The primary objective is to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease

Outcome Measures

Primary Outcome Measures

1. The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. [12-month post ablation]

   The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.

2. The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure. [Seven days post ablation procedure]

   The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.

Secondary Outcome Measures

1. Percentage of Subjects Achieved Acute Success [Duration from post-procedure to hospital discharge, up to 2 days]

   Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.

2. Percentage of Subjects Who Achieved Chronic Effectiveness [6-month follow up]

   Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.

3. Number of Subjects Achieved Long-term Efficacy Success [3-year follow up]

   Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.

4. Change in Left Ventricular Ejection Fraction at 6 Month From Baseline [6-month follow up]

   Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one)

2. For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study.

3. For patients without ICDs: Documented episodes must be two (2) or greater within two (2) months and the assessment will be performed by a review of ECGs and hospitalization records.

4. Incessant VT due to prior myocardial infarction (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion).

5. Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention.

6. Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days.

7. Age eighteen (18) years or older.

8. Signed Patient Informed consent form.

9. Able and willing to comply with all pre-, post-, and follow-up testing requirements.

Exclusion Criteria:

1. Definite protruding left ventricular thrombus on pre-ablation echocardiogram.

2. Myocardial infarction within the preceding two (2) months. Patients with incessant VT (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion) may be enrolled if their MI is at least three (3) weeks old.

3. Patients with idiopathic VT.

4. Other disease process likely to limit survival to less than twelve (12) months.

5. Class IV heart failure.

6. Serum creatinine of > 2.5 mg/dl.

7. Thrombocytopenia (defined as platelet count <80,000) or coagulopathy.

8. Contraindication to heparin.

9. Women who are pregnant.

10. Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past two (2) months. Patients with incessant VT (present 50% of the time with intervention for a period >12

1. may be enrolled if their surgery is at least three (3) weeks old.

1. Acute illness or active systemic infection.

2. Unstable angina.

3. Severe aortic stenosis or flail mitral valve.

4. Uncontrolled heart failure.

5. Significant congenital anomaly or medical problem that, in the opinion of the Principal Investigator, would preclude enrollment in the study.

6. Enrolled in an investigational study evaluating another device or drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama, Birmingham	Birmingham	Alabama	United States	35294
2	Arizona Arrhythmia Consultants	Scottsdale	Arizona	United States	85251
3	Good Samaritan Hospital	Los Angeles	California	United States	90017
4	Stanford University School of Medicine	Stanford	California	United States	94305
5	Florida Hospital	Orlando	Florida	United States	32803
6	University of Chicago	Chicago	Illinois	United States	60637
7	University of Maryland	Baltimore	Maryland	United States	21201
8	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
9	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
10	University of Michigan	Ann Arbor	Michigan	United States	48109
11	Henry Ford Hospital	Detroit	Michigan	United States	48202
12	Mayo Clinic Foundation	Rochester	Minnesota	United States	55902
13	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
14	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
15	Penn State University	Hershey	Pennsylvania	United States	17033
16	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
17	Texas Cardiac Arrhythmia Research - St. David's	Austin	Texas	United States	78705
18	University of Vermont	Burlington	Vermont	United States	05401

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT00412607
• Other Study ID Numbers: BWI40036
• First Posted: Dec 18, 2006
• Last Update Posted: Nov 5, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Biosense Webster, Inc.: Ventricular Tachycardia; Heart Diseases; Arrhythmia
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled on April 3, 2007. Subject enrollment was completed on May 19, 2009 after reaching the minimum enrollment criteria of two hundred forty-nine (249) subjects. Subject follow-up was completed on June 8, 2012.

Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
Period Title: Overall Study
STARTED	249
Started Study Catheter	233
COMPLETED	145
NOT COMPLETED	104

Baseline Characteristics

Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
Overall Participants	249
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.4 (9.8)
Sex: Female, Male (Count of Participants)
Female	15 6%
Male	234 94%
Race/Ethnicity, Customized (participants) [Number]
Asian	0 0%
Black	14 5.6%
Caucasian	229 92%
Hispanic	4 1.6%
Other	2 0.8%
Region of Enrollment (participants) [Number]
United States	249 100%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
Description	The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.
Time Frame	12-month post ablation

Outcome Measure Data

Analysis Population Description

Safety analysis population - subjects who underwent insertion of the study catheter.

Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
Measure Participants	233
Number (95% Confidence Interval) [percentage of mortality]	13.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVISTAR THERMOCOOL Catheter
	Comments	Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method. The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of mortality
	Estimated Value	13.3
	Confidence Interval	(1-Sided) 95%; to 17.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.

2. Secondary Outcome

Title	Percentage of Subjects Achieved Acute Success
Description	Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.
Time Frame	Duration from post-procedure to hospital discharge, up to 2 days

Outcome Measure Data

Analysis Population Description

Subjects in the efficacy analysis cohort who had targeted ventricular tachycardia ablated were included. Efficacy Analysis Cohort includes subjects who are enrolled and treated with the study catheter in compliance with the protocol and treated specifically for the study-related arrhythmia.

Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
Measure Participants	215
Number [Percentage of participants]	74.9 30.1%

3. Primary Outcome

Title	The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.
Description	The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.
Time Frame	Seven days post ablation procedure

Outcome Measure Data

Analysis Population Description

Safety Analysis Cohort - defined as subjects who underwent insertion of the study catheter.

Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
Measure Participants	233
Number (95% Confidence Interval) [percentage of Adverse Event]	4.3

4. Secondary Outcome

Title	Percentage of Subjects Who Achieved Chronic Effectiveness
Description	Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Subjects in the Efficacy analysis cohort who had available chronic effectiveness outcomes were included

Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
Measure Participants	184
Number [Percentage of participants]	62.0 24.9%

5. Secondary Outcome

Title	Number of Subjects Achieved Long-term Efficacy Success
Description	Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.
Time Frame	3-year follow up

Outcome Measure Data

Analysis Population Description

Subjects in the efficacy analysis cohort who completed 12-month, 2-year, or 3-year follow-up and had available long-term efficacy outcomes at the corresponding time points were included.

Arm/Group Title	Total	Reported Recurrence	Reported No Recurrence
Arm/Group Description	Total number of subjects who completed 12-month, 2-year, and 3-year follow-up respectively.	Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit	Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
Measure Participants	176	176	176
12-Month Follow-up	176 70.7%	40 NaN	136 NaN
2-Year Follow-up	161 64.7%	48 NaN	113 NaN
3-Year Follow-up	141 56.6%	34 NaN	107 NaN

6. Secondary Outcome

Title	Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
Description	Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Efficacy analysis cohort subjects with LVEF data available. The statistics for Baseline and 6-month were based on data available from 219 and 166 subjects respectively; the mean change was based on 163 subjects with data at both Baseline and 6-month. Hence the mean change is not the simple subtraction between Baseline and 6-month.

Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
Measure Participants	219
Baseline (Pre-Ablation)	30.6 (12.5)
6-Month	32.9 (11.53)
Change from Baseline	0.9 (8.23)

Adverse Events

Time Frame	3-year follow up
Adverse Event Reporting Description	Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
Arm/Group Title	NAVISTAR THERMOCOOL Catheter
Arm/Group Description	NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
All Cause Mortality
	NAVISTAR THERMOCOOL Catheter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	NAVISTAR THERMOCOOL Catheter
	Affected / at Risk (%)	# Events
Total	37/233 (15.9%)
Cardiac disorders
Bradycardia	1/233 (0.4%)	1
Death	3/233 (1.3%)	3
Congestive Heart Failure	5/233 (2.1%)	5
Palpitations	1/233 (0.4%)	1
Pericardial Effusion	3/233 (1.3%)	3
Coronary Artery Disease Intervention	1/233 (0.4%)	1
Ventricular Tachycardia	8/233 (3.4%)	8
Pulseless Electrical Activity at Device Site	1/233 (0.4%)	1
Infections and infestations
Staphylococcus	1/233 (0.4%)	1
Fever	1/233 (0.4%)	1
MRSA	2/233 (0.9%)	2
Pneumonia	1/233 (0.4%)	1
Sepsis	1/233 (0.4%)	1
Urinary Tract Infection/Urinary Retention Retention	5/233 (2.1%)	6
Injury, poisoning and procedural complications
Fluid Overload	1/233 (0.4%)	1
AV Fistula	1/233 (0.4%)	1
Aortoiliac Dissection	1/233 (0.4%)	1
Thrombus	1/233 (0.4%)	1
Hematoma	1/233 (0.4%)	1
Hemodynamically Unstable	1/233 (0.4%)	1
Pseudoaneurysm	2/233 (0.9%)	2
Tamponade	1/233 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	1/233 (0.4%)	1
Renal Failure	3/233 (1.3%)	3
Adult Respiratory Failure	1/233 (0.4%)	1
Other (Not Including Serious) Adverse Events
	NAVISTAR THERMOCOOL Catheter
	Affected / at Risk (%)	# Events
Total	177/233 (76%)
Blood and lymphatic system disorders
Anemia	1/233 (0.4%)	1
Cardiac disorders
Atrioventricular node ablation	1/233 (0.4%)	1
Angina pectoris	6/233 (2.6%)	6
Arrhythmia - Not Elsewhere Classified	6/233 (2.6%)	7
Atrial Tachycardia	5/233 (2.1%)	5
Atrial fibrillation	22/233 (9.4%)	30
Biventricular assist device placed	1/233 (0.4%)	1
Bradycardia	1/233 (0.4%)	1
Cardiac - Not Elsewhere Classified	6/233 (2.6%)	6
Cardiac Arrest	3/233 (1.3%)	3
Cardiac stents	4/233 (1.7%)	4
Chest Pain - Not Elsewhere Classified	3/233 (1.3%)	3
Congestive Heart Failure	50/233 (21.5%)	78
Coronary Artery Disease	6/233 (2.6%)	6
Endocarditis	1/233 (0.4%)	1
Heart Block	3/233 (1.3%)	3
Heart Transplant	2/233 (0.9%)	2
Implantable Cardioverter Defibrillator maintenance	10/233 (4.3%)	10
Implantable Cardioverter Defibrillator shock - Not Elsewhere Classified	10/233 (4.3%)	12
Mitral valve regurgitation	2/233 (0.9%)	3
Myocardial Infarction	5/233 (2.1%)	5
Pericardial effusion	2/233 (0.9%)	2
Pleural Effusion	2/233 (0.9%)	2
Thrombus	4/233 (1.7%)	4
Ventricular Tachycardia	68/233 (29.2%)	125
Gastrointestinal disorders
Abdominal pain - Not Elsewhere Classified	1/233 (0.4%)	1
Appendicitis	1/233 (0.4%)	1
Ascites	1/233 (0.4%)	1
Colitis	1/233 (0.4%)	1
Esophageal cancer	1/233 (0.4%)	1
Gastrointestinal bleed	3/233 (1.3%)	3
Ulcer	1/233 (0.4%)	1
General disorders
Chest Pain - Not Elsewhere Classified	5/233 (2.1%)	9
Chest Pain - Non cardiac	6/233 (2.6%)	6
Diabetes	1/233 (0.4%)	1
Elective - Dental	1/233 (0.4%)	1
Fluid overload	3/233 (1.3%)	3
Pain - Not Elsewhere Classified	1/233 (0.4%)	1
Weakness	3/233 (1.3%)	3
Chest Pain - Not Elsewhere Classified	1/233 (0.4%)	1
Infections and infestations
Bacteremia	1/233 (0.4%)	1
Bronchitis	2/233 (0.9%)	2
Fever	2/233 (0.9%)	2
Gangrene	1/233 (0.4%)	1
Infection - Not Elsewhere Classified	2/233 (0.9%)	2
Knee infection	1/233 (0.4%)	2
Methicillin-resistant Staphylococcus aureus	1/233 (0.4%)	1
Pneumonia	8/233 (3.4%)	9
Prostatitis	1/233 (0.4%)	1
Sepsis	7/233 (3%)	7
Urinary Tract Infections	1/233 (0.4%)	1
Viral infection	2/233 (0.9%)	2
Injury, poisoning and procedural complications
Arteriovenous fistula	1/233 (0.4%)	1
Cardiac - Not Elsewhere Classified	2/233 (0.9%)	2
Fracture - Fibula	1/233 (0.4%)	2
Fracture - hip	1/233 (0.4%)	1
Fracture - jaw	1/233 (0.4%)	1
Fracture - pelvis	1/233 (0.4%)	1
Fracture - rib	1/233 (0.4%)	1
Fracture - wrist	1/233 (0.4%)	1
Hematoma	9/233 (3.9%)	9
Pseudoaneurysm	2/233 (0.9%)	2
Spider bite	1/233 (0.4%)	1
Wound - Not Elsewhere Classified	1/233 (0.4%)	1
Investigations
Death	12/233 (5.2%)	12
Transplant - Not Elsewhere Classified	1/233 (0.4%)	1
Metabolism and nutrition disorders
Hypokalemia	6/233 (2.6%)	6
Musculoskeletal and connective tissue disorders
Arthritis	1/233 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowel Cancer	1/233 (0.4%)	1
Cancer	1/233 (0.4%)	1
Lung cancer	2/233 (0.9%)	2
Cysts	1/233 (0.4%)	1
Pancreatic Cancer	1/233 (0.4%)	1
Nodule	1/233 (0.4%)	1
Nervous system disorders
Ataxia	1/233 (0.4%)	1
Cerebrovascular accident	1/233 (0.4%)	1
Neuropathy	1/233 (0.4%)	1
Stroke	2/233 (0.9%)	2
Syncope	1/233 (0.4%)	2
Vertigo	1/233 (0.4%)	1
Visual disturbance	1/233 (0.4%)	1
Psychiatric disorders
Schizophrenia	1/233 (0.4%)	1
Renal and urinary disorders
Renal - Not Elsewhere Classified	1/233 (0.4%)	1
Renal Failure	5/233 (2.1%)	5
Hematuria	1/233 (0.4%)	1
Kidney stone	1/233 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/233 (0.4%)	1
Chronic obstructive pulmonary disease	5/233 (2.1%)	5
Diaphragmatic paralysis	1/233 (0.4%)	1
Dyspnea	1/233 (0.4%)	1
Edema	1/233 (0.4%)	1
Epitaxis	2/233 (0.9%)	2
Fibrosis	1/233 (0.4%)	1
Vascular disorders
Aortic Aneurysm	3/233 (1.3%)	3
Hypertension	2/233 (0.9%)	2
Hypotension	5/233 (2.1%)	5
Revascularization	1/233 (0.4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Please contact Biosense Webster for additional information.