Trial Outcomes & Findings for Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial (NCT NCT03646643)
NCT ID: NCT03646643
Last Updated: 2024-11-29
Results Overview
The primary endpoint of the study is recurrence rate 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±45 days post-ablation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Time to atrial arrhythmia recurrence will be recorded as time to the first ECG or monitor that shows atrial arrhythmia recurrence between the end of the blanking period (90 days post ablation) and the end of the study (180±45 days post ablation).
Results posted on
2024-11-29
Participant Flow
The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time atrial fibrillatoin ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019 (PRECAF \[Prospective Elimination of Distal Coronary Sinus to Left Atrial Connection for Atrial Fibrillation Ablation\])
Participant milestones
| Measure |
PVI, Non-PV Triggers Ablation
Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation.
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.
|
PVI, Non-PV Triggers Ablation & Elimination of Distal CS-LA Connection
Interventions: AF ablation, including conventional PVI and non-PV triggers ablation in addition to coronary sinus (CS)-left atrium (LA) connection elimination. Distal CS pacing will be utilized to localize the earliest connection (aside from septal) from the CS to the LA musculature. Once localized, focal radiofrequency lesions will be applied at the discretion of the investigator until distal CS to LA connections are eliminated.
If vein of Marshall connections to the LA are present, differential pacing will be utilized to prove the lack of distal CS to LA connections.
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) 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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
PVI, Non-PV Triggers Ablation
Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation.
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.
|
PVI, Non-PV Triggers Ablation & Elimination of Distal CS-LA Connection
Interventions: AF ablation, including conventional PVI and non-PV triggers ablation in addition to coronary sinus (CS)-left atrium (LA) connection elimination. Distal CS pacing will be utilized to localize the earliest connection (aside from septal) from the CS to the LA musculature. Once localized, focal radiofrequency lesions will be applied at the discretion of the investigator until distal CS to LA connections are eliminated.
If vein of Marshall connections to the LA are present, differential pacing will be utilized to prove the lack of distal CS to LA connections.
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) 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.
|
|---|---|---|
|
Overall Study
Not yet achieved 6 months study follow-up at the time of analysis
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
Baseline characteristics by cohort
| Measure |
PVI, Non-PV Triggers
n=17 Participants
Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation.
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.
|
PVI, Non-PV Triggers & CS-LA Connection
n=18 Participants
Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation in addition to coronary sinus-left atrium connection elimination.
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.
In persistent atrial fibrillation patients, cardioversion can be performed if rhythm cannot be restored to sinus rhythm after PVI with/without posterior wall box isolation. Then, distal coronary sinus pacing will be utilized to localize the earliest connection (aside from septal) from the coronary sinus to the left atrial musculature. Once localized, focal radiofrequency lesions will be applied at the discretion of the investigator until distal coronary sinus to left atrial connections are eliminated. 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.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
0 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
8 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
13 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
|
Age, Categorical
>=65 years
|
10 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
7 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
17 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 6.1 • n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
64.6 years
STANDARD_DEVIATION 8.3 • n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
65.6 years
STANDARD_DEVIATION 7.2 • n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019.
|
|
Sex: Female, Male
Female
|
9 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
5 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
14 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Sex: Female, Male
Male
|
6 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
10 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
16 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
1 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
2 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
1 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
2 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Race (NIH/OMB)
White
|
13 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
13 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
26 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
0 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
15 Participants
n=15 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
30 Participants
n=30 Participants • The study is a single-center, randomized, controlled trial, enrolling drug-refractory symptomatic patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Four patients had not achieve 6 months study follow-up at the time of analysis; there was one patient loss follow-up.
|
PRIMARY outcome
Timeframe: Time to atrial arrhythmia recurrence will be recorded as time to the first ECG or monitor that shows atrial arrhythmia recurrence between the end of the blanking period (90 days post ablation) and the end of the study (180±45 days post ablation).The primary endpoint of the study is recurrence rate 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±45 days post-ablation.
Outcome measures
| Measure |
PVI, Non-PV Triggers Ablation Isolation and Non-pulmonary Vein Trigger Ablation
n=15 Participants
Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation.
Standard Atrial fibrillation ablation: The AF ablation procedures should follow the sequence below: Diagnostic catheter placement Electrophysiology study; Trans-septal 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.
|
PVI, Non-PV Triggers Ablation+Elimination of Distal CS to LA Connections
n=15 Participants
Interventions: AF ablation, including conventional PVI and non-PV triggers ablation in addition to coronary sinus (CS)-left atrium (LA) connection elimination. Distal CS pacing will be utilized to localize the earliest connection (aside from septal) from the CS to the LA musculature. Once localized, focal radiofrequency lesions will be applied at the discretion of the investigator until distal CS to LA connections are eliminated. If vein of Marshall connections to the LA are present, differential pacing will be utilized to prove the lack of distal CS to LA connections.
If persistent atrial fibrillation cannot be restored to sinus rhythm after PVI, cardioversion with/without posterior wall box isolation can be performed. Then, non-PV triggers can be evaluated and distal CS-pacing can be ultilized to identify the CS to LA connection.
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).
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.
|
|---|---|---|
|
Recurrence Rate of Atrial Arrhythmias
No Atrial Arrhythmia Recurrence
|
8 participants
|
14 participants
|
|
Recurrence Rate of Atrial Arrhythmias
Atrial Arrhythmia Recurrence
|
7 participants
|
1 participants
|
Adverse Events
PVI, Non-PV Triggers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PVI, Non-PV Triggers & CS-LA Connection
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PVI, Non-PV Triggers
n=15 participants at risk
Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation.
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.
|
PVI, Non-PV Triggers & CS-LA Connection
n=15 participants at risk
Interventions: AF ablation, including conventional PVI and non-PV triggers ablation in addition to coronary sinus (CS)-left atrium (LA) connection elimination. Distal CS pacing will be utilized to localize the earliest connection (aside from septal) from the CS to the LA musculature. Once localized, focal radiofrequency lesions will be applied at the discretion of the investigator until distal CS to LA connections are eliminated.
If vein of Marshall connections to the LA are present, differential pacing will be utilized to prove the lack of distal CS to LA connections.
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) 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.
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.00%
0/15 • The study enrolled drug-refractory symptomatic AF patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Regular clinic visits at 6 weeks and 6 months post-ablation were arranged and adverse events were recorded.
One patient was readmitted with pericarditis. Pericardiocentesis was performed with drainage of 200 mL serous pericardial effusion 16 days following ablation, which included PV isolation (35 minutes radiofrequency \[RF\] time), mitral isthmus line (10 minutes RF time), and distal CS to LA connection elimination (1.5 minutes RF time)--no clearly attributed to the strategy of distal CS to LA connection elimination. The patient recovered and was discharged on anticoagulation without further sequela.
|
6.7%
1/15 • Number of events 1 • The study enrolled drug-refractory symptomatic AF patients who presented for first-time ablation at the Hospital of the University of Pennsylvania between August 2018 and August 2019. Atrial arrhythmia recurrence at follow-up was reported with a time-to-event analysis with censoring on November 20, 2019. Regular clinic visits at 6 weeks and 6 months post-ablation were arranged and adverse events were recorded.
One patient was readmitted with pericarditis. Pericardiocentesis was performed with drainage of 200 mL serous pericardial effusion 16 days following ablation, which included PV isolation (35 minutes radiofrequency \[RF\] time), mitral isthmus line (10 minutes RF time), and distal CS to LA connection elimination (1.5 minutes RF time)--no clearly attributed to the strategy of distal CS to LA connection elimination. The patient recovered and was discharged on anticoagulation without further sequela.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place