Trial Outcomes & Findings for Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (NCT NCT01687036)

Results Overview

The primary study objective is assessed by recording all Serious Adverse Events (SAEs). Primary endpoint: measurement of the following parameters: * deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment). * phrenic nerve palsy during visit 3 (treatment). * onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion. * onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

3 months

Results posted on

2018-12-06

Participant Flow

Recruitment period: September 3,2012 - December 14, 2012 Locations: Medical University Innsbruck, General Hospital Linz

Participant milestones

Participant milestones
Measure	Cryoablation Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	57.6 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Austria	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

The primary study objective is assessed by recording all Serious Adverse Events (SAEs). Primary endpoint: measurement of the following parameters: * deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment). * phrenic nerve palsy during visit 3 (treatment). * onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion. * onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)	6 participants

PRIMARY outcome

Timeframe: Treatment duration, up to 6 hours

The primary study objective is assessed by recording all Adverse Events (AEs). Primary endpoint: measurement of the following parameters: \- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Tolerability of Ablation Using the AFreeze Cryoablation System	1 AE (device related)

SECONDARY outcome

Timeframe: Treatment Duration

Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.	10 participants

SECONDARY outcome

Timeframe: Treatment Duration

Absolute percentage of PVs isolated with the CoolLoop® catheter.

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Acute Efficacy of Catheter Ablation	57.5 percentage of isolated PVs

SECONDARY outcome

Timeframe: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013

During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Clinical Efficacy of Catheter Ablation	2 participants

SECONDARY outcome

Timeframe: Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)

Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Procedure Time	251.1 minutes Standard Deviation 59.7

SECONDARY outcome

Timeframe: Treatment Duration

Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time. Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. - 59 min.).

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Fluoroscopy Time	44 minutes Standard Deviation 13.2

SECONDARY outcome

Timeframe: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013

Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient. Average cryoablation time was 114 min. 33 sec. (range 80 - 130 min.).

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Cumulative Cryoablation Time	113.9 minutes Standard Deviation 18.1

SECONDARY outcome

Timeframe: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013

18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.

Outcome measures

Outcome measures
Measure	Cryoablation n=10 Participants Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
AE	7 participants

Adverse Events

Cryoablation

Serious events: 6 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cryoablation n=10 participants at risk Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Surgical and medical procedures groin hematoma	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Cardiac disorders Hospitalization	50.0% 5/10 • Number of events 5 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.

Other adverse events

Other adverse events
Measure	Cryoablation n=10 participants at risk Cryoablation Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Vascular disorders air embolism	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Musculoskeletal and connective tissue disorders neck pain	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Endocrine disorders hyperthyreosis factitis	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Vascular disorders groin hematoma with art. bleeding	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Blood and lymphatic system disorders anemia	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Musculoskeletal and connective tissue disorders back pain	30.0% 3/10 • Number of events 3 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Cardiac disorders atrial fibrillation	20.0% 2/10 • Number of events 2 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Cardiac disorders Hospitalization	20.0% 2/10 • Number of events 2 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Surgical and medical procedures catheter loop not retractable to straight position	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Gastrointestinal disorders dyspepsia	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Eye disorders burning eyes	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Cardiac disorders dyscardia	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
Vascular disorders intermittent ST elevation	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.
General disorders dizzyness	10.0% 1/10 • Number of events 1 • First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days) Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.

Additional Information

Markus Stühlinger, MD

Medical University Innsbruck, Department of Internal Medicine III, Cardiology

Phone: +43 512 504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following approval of the Sponsor and before publishing or presenting data related to the Trial or the Device, Research lnstitution, Principal lnvestigator, and Co-lnvestigator agree to submit copies of any and all proposed manuscripts or abstracts to Sponsor at least 30 days in advance of the date that the applicable party proposes to submit such proposed manuscripts or abstracts to a publisher or other third party.
Publication restrictions are in place

Restriction type: OTHER