Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System (CONTACT_AFL)
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|ClinicalTrials.gov Identifier: NCT01401361|
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : December 23, 2013
Last Update Posted : February 15, 2019
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter
- Does not result into unacceptable risk of intra-procedural composite serious adverse events and,
- Does not affect efficacy of the ablation procedure The study will also evaluate the
|Condition or disease||Intervention/treatment||Phase|
|Typical Atrial Flutter||Device: Treatment Arm||Phase 3|
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study
- Validation of ECI against conventional methods of assessing tip tissue contact and
Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:
- Query regarding adverse events since the last visit
- Assessment of anti-arrhythmic and anti-coagulation medication
- Query regarding recurrence or repeat ablation for typical atrial flutter
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Treatment Arm
Atrial Flutter RF Ablation treatment with the Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement.
Device: Treatment Arm
The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
Other Name: Ablation with Contact Therapy Cool Path system
- Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure [ Time Frame: 7 days ]Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
- Primary Efficacy [ Time Frame: 30 minutes ]Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
- Secondary Efficacy [ Time Frame: 3 months ]
Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,
1c, III) during the 3 months post ablation are considered chronic failures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401361
|Principal Investigator:||Larry Chinitz, MD||NYU Langone Health|