AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment (ICE-AFIB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03732794|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation||Device: AtriCure CryoICE & AtriClip LAA Exclusion||Not Applicable|
The AtriCure CryoICE Ablation System is being studied to ablate cardiac tissue during surgery for the treatment of Persistent and Long-standing Persistent atrial fibrillation in open concomitant cardiac surgery.
The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery|
|Actual Study Start Date :||January 30, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2023|
Experimental: AtriCure CryoICE & AtriClip LAA Exclusion
AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
Device: AtriCure CryoICE & AtriClip LAA Exclusion
AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
- Primary Effectiveness Endpoint: Freedom from AF/AFL/AT [ Time Frame: 12 months ]Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure in the absence of Class I or III AADs.
- Safety Endpoint: composite acute major adverse event (MAE) rate [ Time Frame: 30 days ]The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related.
- Composite post-procedure MAE rate (Safety). [ Time Frame: 12 months ]Long-term safety based on MAE rate at 12-months post-procedure
- Pacemaker implantation (Safety). [ Time Frame: 12 months ]Percentage of implantation of a permanent pacemaker either in the operative period (<30 days postoperative) or at any time during follow-up period.
- Overall SAE rate (Safety) [ Time Frame: 12 months ]Long-term safety based on SAE rate at 12-months post-procedure
- Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness) [ Time Frame: 12 months ]Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure in presence of previously failed Class I or III AADs.
- Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness) [ Time Frame: 12 months ]Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure regardless of Class I or III AADs.
- AFEQT QoL Score (Effectiveness) [ Time Frame: 12 months ]
Based on composite score (0-100). A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).
AFEQT Evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients The overall composite score and domains will be summarized by presenting the means, medians, standard deviations, interquartile ranges, minimum, and maximum
- Acute procedural success (Effectiveness) [ Time Frame: Intra-operative period ]Absence of AF at end of procedure
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): NCT03732794
|Contact: Nfii K Ndikintum, PhD, MBAfirstname.lastname@example.org|
|Contact: Maria Rhoades, CCRP, MSNemail@example.com|
|United States, District of Columbia|
|Washington Adventist Hospital||Recruiting|
|Washington, District of Columbia, United States, 20912|
|Contact: Ying Yuan, RN,BSN,MHA 301-891-5612|
|Principal Investigator: Niv Ad, MD|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46237|
|Contact: Angela Cainfield, RN 317-893-1916|
|Principal Investigator: Marc W Gerdisch, MD|
|United States, New York|
|Mount Sinai Icahn School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Michael Fusilero 212-241-8905|
|Principal Investigator: David Adams, MD|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Tom Callihan 216-444-0379|
|Principal Investigator: Marc Gillinov, MD|
|Principal Investigator:||Niv Ad, MD||Washington Adventist Hospital|