Trial Outcomes & Findings for Ablation of the Pulmonary Veins for Paroxysmal Afib (NCT NCT00744874)

NCT ID: NCT00744874

Last Updated: 2018-09-19

Results Overview

Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-09-19

Participant Flow

Participant milestones

Measure	Ablated Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
Overall Study STARTED	55
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Ablated Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1
Overall Study Study Device not available at procedure	1
Overall Study Unable to accomodate schedule	1

Baseline Characteristics

Ablation of the Pulmonary Veins for Paroxysmal Afib

Baseline characteristics by cohort

Measure	Ablated Participants n=55 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
Age, Continuous	55.6 years STANDARD_DEVIATION 10.1 • n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	34 Participants n=93 Participants
Region of Enrollment Denmark	18 participants n=93 Participants
Region of Enrollment Germany	7 participants n=93 Participants
Region of Enrollment Netherlands	21 participants n=93 Participants
Region of Enrollment Switzerland	9 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Subjects that had successful pulmonary vein isolation.

Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.

Outcome measures

Measure	Ablated Participants n=55 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Number of Participants With Successful Pulmonary Vein Isolation	53 participants	—	—

PRIMARY outcome

Timeframe: 6 months

Population: The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.

The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.

Outcome measures

Measure	Ablated Participants n=55 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Chronic Effectiveness	10 participants Interval 9.1 to 30.9	—	—

PRIMARY outcome

Timeframe: 7 days post procedure

Population: The proportion of subjects with one or more serious procedure and/or device related AEs occurring within 7 days of the ablation procedure. No acute events were related to the device.

The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.

Outcome measures

Measure	Ablated Participants n=55 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Acute Safety	2 participants	—	—

PRIMARY outcome

Timeframe: 7 day post procedure to 6 months

Population: The Chronic Safety Endpoint is the proportion of subjects with serious procedure and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.

The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.

Outcome measures

Measure	Ablated Participants n=55 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Chronic Safety	0 participants	—	—

SECONDARY outcome

Timeframe: 6 Months

Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).

Outcome measures

Measure	Ablated Participants n=54 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months n=50 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months n=51 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months Lack of Energy During Exertion or Exercise	3.3 units on a scale Standard Deviation 0.9	2.1 units on a scale Standard Deviation 1.1	2.1 units on a scale Standard Deviation 1.3
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months Total AF Symptom Severity Score	15.4 units on a scale Standard Deviation 4.1	9.4 units on a scale Standard Deviation 4.4	9.2 units on a scale Standard Deviation 4.7
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months Palpitations	3.4 units on a scale Standard Deviation 1	1.9 units on a scale Standard Deviation 1	1.9 units on a scale Standard Deviation 1
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months Fatigue	3.2 units on a scale Standard Deviation 1.1	2 units on a scale Standard Deviation 1.2	1.9 units on a scale Standard Deviation 1.1
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months Shortness of Breath	2.7 units on a scale Standard Deviation 1.2	1.9 units on a scale Standard Deviation 1.1	1.8 units on a scale Standard Deviation 1.1
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months Lightheadedness / Dizziness	2.7 units on a scale Standard Deviation 1.2	1.5 units on a scale Standard Deviation 0.9	1.5 units on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: 6 months

The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score.

Outcome measures

Measure	Ablated Participants n=48 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months n=50 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months n=51 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline Physical Component Score	46.4 units on a scale Standard Deviation 9.7	50.4 units on a scale Standard Deviation 9.2	51.8 units on a scale Standard Deviation 8.1
The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline Mental Compnent Score	46.8 units on a scale Standard Deviation 11.7	49.4 units on a scale Standard Deviation 10	51.6 units on a scale Standard Deviation 9

SECONDARY outcome

Timeframe: After Procedure

Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation

Outcome measures

Measure	Ablated Participants n=53 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins	56.3 minutes Standard Deviation 37.1	—	—

SECONDARY outcome

Timeframe: End of Procedure

Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)

Outcome measures

Measure	Ablated Participants n=54 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Total Procedure Time	117.9 minutes Standard Deviation 58.2	—	—

SECONDARY outcome

Timeframe: Post Ablation Procedure

Total time that flouroscopy was used during the ablation procedure.

Outcome measures

Measure	Ablated Participants n=53 Participants Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.	Ablated Patients Symptom Severity Score at 3 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.	Ablated Patients Symptom Severity Score at 6 Months Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
Total Fluoroscopy Time	26 minutes Standard Deviation 15.4	—	—

Adverse Events

Ablated Participants

Serious events: 9 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ablated Participants n=55 participants at risk Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
Surgical and medical procedures Bleeding	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Surgical and medical procedures Chest Discomfort	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Cardiac disorders Collapse After AF recurrence	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Cardiac disorders Arrythmia, pro arrhythmia	5.5% 3/55 • Number of events 3 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
General disorders Dizziness	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Ear and labyrinth disorders Sudden Deafness followed by tinnitus	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Surgical and medical procedures Heart Catheterization	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Vascular disorders Cerebrovascular Accident- Ischemic attack	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.

Other adverse events

Measure	Ablated Participants n=55 participants at risk Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
General disorders Back pain	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Cardiac disorders Arrythmia, proarrythmia	25.5% 14/55 • Number of events 16 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
General disorders Fatigue	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
General disorders Headache	3.6% 2/55 • Number of events 2 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Immune system disorders Allergic reaction	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
General disorders Dizziness	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Cardiac disorders Atrial Fibrillation	5.5% 3/55 • Number of events 3 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Vascular disorders Cerebrovascular Accident/ Ischemic Attack	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
Infections and infestations Infections	1.8% 1/55 • Number of events 1 • All adverse events were collected up to 6 months. The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.

Additional Information

Linda Nelson, RN, BSN, MBA- AF Solutions Clinical Operations Director

Medtronic AF Solutions

Phone: (763)526-2891

Email: linda.k.nelson@medtronic.com

Results disclosure agreements

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

Restriction type: LTE60