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Atrial Pressure Electrophysiology Pilot Study (APES)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01845974
Recruitment Status : Terminated (Interim evaluation of data after internal safety report from sponsor.)
First Posted : May 3, 2013
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Scott Martin Miller, MD, Advocate Health Care

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition: Atrial Fibrillation
Interventions: Device: ThermoCool® SF NAV Catheter
Device: ThermoCool® catheter

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
all patients scheduled for atrial fibrillation ablation referred to study coordinator. Non qualifying reasons include: Clot on TEE;Persistant AFib despite previous treatments;Combo treatment needed for both atrial fibrillation and flutter; Declined participation:Afib the morning of procedure;ICD;Rhythm other than Sinus Rhythm

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Low Flow Catheter

The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.

ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.

High Flow Catheter

The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.

ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.


Participant Flow:   Overall Study
    Low Flow Catheter   High Flow Catheter
STARTED   4   9 
COMPLETED   3   9 
NOT COMPLETED   1   0 
screen failure                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Flow Catheter

The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.

ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.

High Flow Catheter

The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.

ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.

Total Total of all reporting groups

Baseline Measures
   Low Flow Catheter   High Flow Catheter   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   9   13 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (16.5)   61.3  (9)   61.23  (11.08) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   2   3   5 
Male   2   6   8 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   4   9   13 
Comorbidities 
[Units: Participants]
Count of Participants
     
Hypertension   2   5   7 
Heart Failure   2   0   2 
Diabetes   1   2   3 
Obstructive sleep apnea   3   1   4 
Coronary artery disease   2   2   4 
Tobacco history 
[Units: Participants]
Count of Participants
 0   5   5 
Previous therapies 
[Units: Participants]
Count of Participants
     
statin   2   4   6 
angiotensin 2 receptor blockers   1   2   3 
angiotensin converting enzymes   0   3   3 
beta blockers   2   7   9 
digoxin   0   2   2 
spiranolactone   0   0   0 
diuretic   1   0   1 
CHADsVasc 2 score= 2+ [1] 
[Units: Participants]
Count of Participants
 3   9   12 
[1] Congestive heart failure = 1 Hypertension: blood pressure consistently above 140/90 mmHg (or treated hypertension on medication) =1; Age ≥75 years=2 Diabetes Mellitus =1; Prior Stroke or TIA or thromboembolism =2 ;Vascular disease (e.g. peripheral artery disease, myocardial infarction, aortic plaque) =1; Age 65–74 years =1; Sex category female =+1-items are summed to arrive at a score ranging from 0 to 9, with scores >=2 indicating "moderate-high" stroke risk".)
prior cardiac surgery 
[Units: Participants]
Count of Participants
     
pacemaker   0   1   1 
coronary artery bypass grafting   0   1   1 
surgical maze   0   0   0 
right atrial flutter ablation   0   2   2 
prior catheter Radiofrequency ablation for Afib   1   2   3 
Prior Antiarrhythmia drug failure 
[Units: Participants]
Count of Participants
     
none   0   1   1 
sotolol   1   1   2 
dofetilide   0   1   1 
fleccainide   0   2   2 
dronedarone   1   3   4 
ammiodarone and fleccainide   1   0   1 
ammiodarone and dronedarone   0   1   1 


  Outcome Measures

1.  Primary:   Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements   [ Time Frame: Observation period is up to the 24 hours post procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
early termination due to safety memo issued by sponsor


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Scott M. Miller MD
Organization: Advocate Medical Group Cardiology
phone: 847-698-5500
e-mail: scott.miller@advocatehealth.com


Publications:

Responsible Party: Scott Martin Miller, MD, Advocate Health Care
ClinicalTrials.gov Identifier: NCT01845974     History of Changes
Other Study ID Numbers: #5387
First Submitted: May 1, 2013
First Posted: May 3, 2013
Results First Submitted: May 22, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018