Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial

Atrial Fibrillation Clinical Trial

— PRECAF  

Official title:

Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03646643
• Other study ID #: 829990
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 18, 2018
• Est. completion date: August 2021

Study information

• Verified date: September 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted offering improved symptom control for many patients worldwide. However, long-term success rates remain suboptimal. Prior work indicates that distal connections between coronary sinus musculature and the left atrium exist and provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. In this trial, the investigators will examine the efficacy of elimination of distal connection(s) between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias.

Description:

Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted. However, long-term success rates fhave been reported to be as low as 50% and 20% for paroxysmal and persistent AF, respectively. To achieve permanent arrhythmia suppression, repeated ablation procedures are often needed. Prior work indicates that distal connections between coronary sinus musculature and the left atrium provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. In this prospective randomized trial the investigators will define the efficacy of elimination of distal connections between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias. Patients will be randomly assigned to standard of care ablation (pulmonary vein isolation and non pulmonary vein trigger ablations) alone, or standard of care ablation augmented by distal coronary sinus to left atrial connection elimination.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2021
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with paroxysmal or persistent atrial fibrillation; AND Undergoing first AF ablation; AND Age = 18 years.

Exclusion Criteria:

• Previous left atrial ablation; Women currently pregnant; Mental or physical inability to take part in the study; Known terminally ill patients.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation

Intervention

Procedure:
• Standard Atrial fibrillation ablation
The AF ablation procedures should follow the sequence below: Diagnostic catheter placement Electrophysiology study; Transseptal puncture; Left atrial electro-anatomical mapping is required prior to an ablation procedure. Post ablation pacing procedure(s) and/or infusion of cardiac medications to localize triggers/ assess and localize pulmonary vein reconnections (e.g., Adenosine, Isoproterenol 2-20 mcg/min). Study procedure requirements are outlined below: Isolation of all pulmonary veins and Non-pulmonary vein trigger ablation for all patients. Linear ablation lines are only required to treat documented macro-reentry atrial tachycardias and limited to the following targets only: LA roof line, mitral valve isthmus line, LA floor line, right atrial carvotricuspid isthmus linear ablation.
• Coronary sinus to left atrium connection elimination
Distal coronary sinus pacing will be utilized to localize distal connections between the main coronary sinus body and the left atrium. Focal lesions will be applied to early left atrial activation sites, until no distal coronary sinus to left atrial connections are electrically manifest. If vein of marshall connections to the left atrium are present, differential pacing will be utilized to prove the lack of distal coronary sinus to left atrium connections.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (4)

Antz M, Otomo K, Arruda M, Scherlag BJ, Pitha J, Tondo C, Lazzara R, Jackman WM. Electrical conduction between the right atrium and the left atrium via the musculature of the coronary sinus. Circulation. 1998 Oct 27;98(17):1790-5. — View Citation

Chauvin M, Shah DC, Haïssaguerre M, Marcellin L, Brechenmacher C. The anatomic basis of connections between the coronary sinus musculature and the left atrium in humans. Circulation. 2000 Feb 15;101(6):647-52. — View Citation

Huang D, Marine JE, Li JB, Zghaib T, Ipek EG, Sinha S, Spragg DD, Ashikaga H, Berger RD, Calkins H, Nazarian S. Association of Rate-Dependent Conduction Block Between Eccentric Coronary Sinus to Left Atrial Connections With Inducible Atrial Fibrillation a — View Citation

Kim MH, Lin J, Kreilick C, Foltz Boklage SH. Total costs and atrial fibrillation ablation success or failure in Medicare-aged patients in the United States. Adv Ther. 2010 Sep;27(9):600-12. doi: 10.1007/s12325-010-0060-3. Epub 2010 Aug 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrence of atrial arrhythmias	The primary endpoint of the study is time to the recurrence of atrial arrhythmia following ablation. The primary endpoint will be assessed using survival statistical models measuring time to failure among the two study arms. Failure is defined as a non-self-terminating bout of atrial fibrillation, atrial flutter, or atrial tachycardia >30 seconds in duration following the 90-day post-ablation blanking period. If no AF occurs during the study period, censoring will occur at 180 days post-ablation.	Time to AF recurrence will be recorded as time to the first ECG or monitor that shows AF recurrence between the end of the blanking period (90 days post ablation) and the end of the study (180 days post ablation).
Secondary	Atrial fibrillation burden	AF burden will be compared among study groups as a secondary outcome variable. AF burden will be measured from the 30 day monitors.	Follow-up 6 months after ablation. A 30-day event monitor will be used for the 1st and 6th month after ablation to detect the burden of atrial arrhythmias.