STRATUM VT: Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

• Sponsor: Vivek Reddy (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01546207
• Collaborator: Biosense Webster, Inc. (Industry)
• Enrollment: 4
• Locations: 10
• Arm: 1
• Duration (Months): 23
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia; Catheter Ablation; Tachycardia, Ventricular	Procedure: catheter-based ablation	N/A

Detailed Description

Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: catheter-based ablation catheter ablation - a medical procedure used to treat some types of arrhythmia	Procedure: catheter-based ablation; specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia

Outcome Measures

Primary Outcome Measures

1. Catheter Ablation [at time of catheter ablation procedure (intraoperative)]

   The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia

Secondary Outcome Measures

1. ICD Interrogation [baseline and 6 months follow-up]

   Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.

2. Procedural Safety [1 week post-op]

   2) Procedural safety as defined by the number of complication within 1week associated with the procedure.

3. Signal-Average ECG [baseline and post-op day one after procedure]

   Relationship between change in pre/post saECG and success of the step-wise ablation strategy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 to 90 years.

• History of coronary artery disease.

• Presence of, or planned for, an ICD prior to discharge.

• Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.

Exclusion Criteria:

• Ventricular arrhythmia not thought to be due to CAD.

• Unstable angina

• CVA within 30 days.

• Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography

• Pregnancy

• Any condition resulting in an absolute contraindication to anticoagulation

• Inability to follow-up at ICD clinic.

• Inability to give informed consent.

• Non-inducible for sustained monomorphic ventricular tachycardia.

• Prior substrate guided ablation.

• Definite need for epicardial ablation, as determined by the primary operator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama - Birmingham	Birmingham	Alabama	United States	35294
2	Loyola University	Maywood	Illinois	United States	60153
3	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
4	Beth Israel-Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
6	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
7	Hospital Regional Sao Jose	Santa Catarina		Brazil
8	Southlake Regional Health Center	Newmarket	Ontario	Canada
9	Homolka Hospital	Prague		Czechia
10	San Raffaele Hospital	Milan		Italy

Sponsors and Collaborators

• Vivek Reddy
• Biosense Webster, Inc.

Investigators

• Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01546207
• Other Study ID Numbers: GCO 12-0045
• First Posted: Mar 7, 2012
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai: ventricular tachycardia; catheter ablation; VT
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular

Study Results

Participant Flow

Recruitment Details	Patients were recruited from 12/2011 to 7/2013, at a medical clinic at MSSM.

Arm/Group Title	Catheter-based Ablation
Arm/Group Description	catheter ablation - a medical procedure used to treat some types of arrhythmia
Period Title: Overall Study
STARTED	4
COMPLETED	3
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Catheter-based Ablation
Arm/Group Description	catheter ablation - a medical procedure used to treat some types of arrhythmia
Overall Participants	4
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.75 (7.18)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	4 100%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	Catheter Ablation
Description	The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia
Time Frame	at time of catheter ablation procedure (intraoperative)

Outcome Measure Data

Analysis Population Description

Given the small sample size, we did not analyze the data as there would be no statistical significance.

Arm/Group Title	Catheter-based Ablation
Arm/Group Description	catheter ablation - a medical procedure used to treat some types of arrhythmia
Measure Participants	0

2. Secondary Outcome

Title	ICD Interrogation
Description	Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.
Time Frame	baseline and 6 months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Procedural Safety
Description	2) Procedural safety as defined by the number of complication within 1week associated with the procedure.
Time Frame	1 week post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Signal-Average ECG
Description	Relationship between change in pre/post saECG and success of the step-wise ablation strategy
Time Frame	baseline and post-op day one after procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Catheter-based Ablation
Arm/Group Description	catheter ablation - a medical procedure used to treat some types of arrhythmia
All Cause Mortality
	Catheter-based Ablation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Catheter-based Ablation
	Affected / at Risk (%)	# Events
Total	2/4 (50%)
Blood and lymphatic system disorders
pseudoaneurysm with hematoma	1/4 (25%)	4
Cardiac disorders
Ventricular Tachycardia	1/4 (25%)	4
Other (Not Including Serious) Adverse Events
	Catheter-based Ablation
	Affected / at Risk (%)	# Events
Total	2/4 (50%)
Cardiac disorders
pericardial effusion	1/4 (25%)	1
sustained Ventricular Tachycardia	1/4 (25%)	1
Injury, poisoning and procedural complications
fall	1/4 (25%)	1
Renal and urinary disorders
hematuria	1/4 (25%)	1

Limitations/Caveats

Early termination due to poor enrollment. Data analysis not done - there is not enough data for meaningful analysis.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.