Trial Outcomes & Findings for The Conformal Prague Study (NCT NCT04193826)

NCT ID: NCT04193826

Last Updated: 2024-09-24

Results Overview

Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 7 days post-procedure
• Results posted on: 2024-09-24

Participant Flow

Participant milestones

Measure	Non-Valvular A-fib Adults Twenty (20) adult participants with non-valvular atrial fibrillation were assessed and consented to the trial.
Overall Study STARTED	20
Overall Study Screen Failed	1
Overall Study Implanted	19
Overall Study Subject Death	2
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Non-valvular AF Adults n=19 Participants Left atrial appendage closure (LAAC) with the Conformal LAAC device will be performed according to the device Instructions for Use, based on ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing. Left Atrial Appendage Closure: Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing
Age, Customized Age	72.3 years STANDARD_DEVIATION 9.9 • n=19 Participants
Sex: Female, Male Female	11 Participants n=19 Participants
Sex: Female, Male Male	8 Participants n=19 Participants
Region of Enrollment Czechia	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 7 days post-procedure

Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.

Outcome measures

Measure	7 Day Success n=19 Participants All subjects who had a safety event within 7 days of the successful procedure.
Freedom From Major Adverse Events	19 Participants

PRIMARY outcome

Timeframe: 45-days post-procedure

Closure success, defined as device success followed by complete closure or peri-device residual leak ≤5 mm in width

Outcome measures

Measure	7 Day Success n=15 Participants All subjects who had a safety event within 7 days of the successful procedure.
Closure Success No residual flow	12 Participants
Closure Success 1 - 2 mm	3 Participants
Closure Success >2mm	0 Participants

Adverse Events

Study Adverse Event Breakdown

Serious events: 6 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Measure	Study Adverse Event Breakdown n=19 participants at risk All site-reported adverse events.
Cardiac disorders Rapid Ventricular Rate	10.5% 2/19 • Number of events 3 • 12 Months
Cardiac disorders Pericardial Effusion	10.5% 2/19 • Number of events 2 • 12 Months
Cardiac disorders Pulmonary Edema	5.3% 1/19 • 12 Months
Cardiac disorders Device Related Thrombus	5.3% 1/19 • 12 Months
Cardiac disorders Loss of Consciousness	5.3% 1/19 • 12 Months

Other adverse events

Measure	Study Adverse Event Breakdown n=19 participants at risk All site-reported adverse events.
Infections and infestations UTI	10.5% 2/19 • 12 Months
Cardiac disorders Tachyarrhythmia	5.3% 1/19 • 12 Months
General disorders Migrating Pain - Head, Chest, Abd	5.3% 1/19 • 12 Months
General disorders Epistaxis	5.3% 1/19 • 12 Months
General disorders Headaches	5.3% 1/19 • 12 Months
General disorders SQ Hematomas	5.3% 1/19 • 12 Months
Surgical and medical procedures Vomiting	5.3% 1/19 • 12 Months
Cardiac disorders Pericardial Effusion	5.3% 1/19 • 12 Months

Additional Information

Aly Dechert / Manager of Clinical Operations

Conformal Medical, Inc

Phone: (603) 718-8742

Email: adechert@conformalmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place