Trial Outcomes & Findings for Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation (NCT NCT04170621)
NCT ID: NCT04170621
Last Updated: 2024-01-30
Results Overview
Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
30 Days
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
FARAPULSE Endocardial Ablation
Ablation using the FARAPULSE Endocardial Multi Ablation System
Ablation: Ablation using the FARAPULSE Endocardial Multi Ablation System
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
FARAPULSE Endocardial Ablation
n=28 Participants
Ablation using the FARAPULSE Endocardial Multi Ablation System
Ablation: Ablation using the FARAPULSE Endocardial Multi Ablation System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=28 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 7.4 • n=28 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=28 Participants
|
|
Region of Enrollment
Czechia
|
16 Participants
n=28 Participants
|
|
Region of Enrollment
Croatia
|
12 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: 30 DaysOccurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula
Outcome measures
| Measure |
FARAPULSE Endocardial Ablation
n=28 Participants
Ablation using the FARAPULSE Endocardial Multi Ablation System
Ablation: Ablation using the FARAPULSE Endocardial Multi Ablation System
|
|---|---|
|
Safety at 30 Days
|
1 Participants
|
Adverse Events
FARAPULSE Endocardial Ablation
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FARAPULSE Endocardial Ablation
n=28 participants at risk
Ablation using the FARAPULSE Endocardial Multi Ablation System
Ablation: Ablation using the FARAPULSE Endocardial Multi Ablation System
|
|---|---|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Cardiac disorders
Pericardial Effusion
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Eye disorders
Corneal Erosion
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Infections and infestations
Tonsilitis
|
3.6%
1/28 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
FARAPULSE Endocardial Ablation
n=28 participants at risk
Ablation using the FARAPULSE Endocardial Multi Ablation System
Ablation: Ablation using the FARAPULSE Endocardial Multi Ablation System
|
|---|---|
|
Gastrointestinal disorders
Chronic Gastritis
|
10.7%
3/28 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
7.1%
2/28 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Gastric Disorder
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Intestinal Metaplasia
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Vascular disorders
Hematoma
|
7.1%
2/28 • Number of events 2 • 12 months
|
|
Vascular disorders
Epistaxis
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Vascular disorders
Vein Disorder
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Cardiac disorders
AV Block 2nd Degree
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
General disorders
Chest Discomfort
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
General disorders
Infusion site extravasation
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Infections and infestations
Herpes zoster
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.6%
1/28 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place