Trial Outcomes & Findings for Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation (NCT NCT00741611)
NCT ID: NCT00741611
Last Updated: 2012-10-26
Results Overview
A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
12 months
Results posted on
2012-10-26
Participant Flow
Between July 2008 and November 2009, 44 patients were enrolled into the study. The study Sponsor made a business decision in late November 2009 to terminate the trial early; enrollment was closed at that time.
Of the 44 enrolled patients, a total of 36 patients were treated. Treated patients were followed for 12 months.
Participant milestones
| Measure |
Mesh
Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
|
Drug
Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
|
Roll-ins
Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
29
|
|
Overall Study
COMPLETED
|
4
|
1
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Mesh
Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
|
Drug
Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
|
Roll-ins
Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
2
|
Baseline Characteristics
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Mesh
n=4 Participants
Ablation with HD Mesh Ablation System
|
Drug
n=3 Participants
Treatment with anti-arrhythmic drugs
|
Roll-ins
n=29 Participants
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
64.8 years
STANDARD_DEVIATION 6.18 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 9.54 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 9.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
29 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients who were treated with the HD Mesh Ablation System
A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.
Outcome measures
| Measure |
Mesh
n=4 Participants
Ablation with HD Mesh Ablation System
|
Roll-ins
n=29 Participants
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
Roll-ins
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
|---|---|---|---|
|
Number of Participants With Major Complications
|
0 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All treated patients.
Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.
Outcome measures
| Measure |
Mesh
n=4 Participants
Ablation with HD Mesh Ablation System
|
Roll-ins
n=3 Participants
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
Roll-ins
n=29 Participants
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
|---|---|---|---|
|
Number of Participants With Serious Atrial Fibrillation Events
|
1 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All treated patients
Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: All mesh treated patients.
Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.
Outcome measures
| Measure |
Mesh
n=4 Participants
Ablation with HD Mesh Ablation System
|
Roll-ins
n=29 Participants
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
Roll-ins
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
|---|---|---|---|
|
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: During the mesh ablation procedurePopulation: All mesh treated patients.
Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter
Outcome measures
| Measure |
Mesh
n=4 Participants
Ablation with HD Mesh Ablation System
|
Roll-ins
n=29 Participants
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
Roll-ins
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
|---|---|---|---|
|
Number of Participants With Acute Procedural Success in Mesh Treated Patients.
|
4 participants
|
23 participants
|
—
|
Adverse Events
Mesh
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Drug
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Roll-ins
Serious events: 16 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mesh
n=4 participants at risk
Ablation with HD Mesh Ablation System
|
Drug
n=3 participants at risk
Treatment with anti-arrhythmic drugs
|
Roll-ins
n=29 participants at risk
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
|---|---|---|---|
|
Investigations
Prothrombin time shortened
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
20.7%
6/29 • Number of events 7 • 12 months post procedure
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
13.8%
4/29 • Number of events 4 • 12 months post procedure
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Investigations
Heart rate increased
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Renal and urinary disorders
Myoglobinuria
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
Other adverse events
| Measure |
Mesh
n=4 participants at risk
Ablation with HD Mesh Ablation System
|
Drug
n=3 participants at risk
Treatment with anti-arrhythmic drugs
|
Roll-ins
n=29 participants at risk
Investigator's first patients treated with mesh prior to the start of the study randomization.
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
31.0%
9/29 • Number of events 9 • 12 months post procedure
|
|
Cardiac disorders
Atrial flutter
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
10.3%
3/29 • Number of events 3 • 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Nervous system disorders
Carpal tunnel syndrome
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
10.3%
3/29 • Number of events 3 • 12 months post procedure
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
General disorders
Fatigue
|
0.00%
0/4 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Vascular disorders
Hematoma
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Renal and urinary disorders
Hematuria
|
50.0%
2/4 • Number of events 2 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
10.3%
3/29 • Number of events 4 • 12 months post procedure
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
10.3%
3/29 • Number of events 3 • 12 months post procedure
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
General disorders
Edema peripheral
|
0.00%
0/4 • 12 months post procedure
|
33.3%
1/3 • Number of events 1 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
6.9%
2/29 • Number of events 2 • 12 months post procedure
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Infections and infestations
Urinary tract infection
|
50.0%
2/4 • Number of events 2 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
3.4%
1/29 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Ventricular tachycardia
|
25.0%
1/4 • Number of events 1 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
0.00%
0/29 • 12 months post procedure
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • 12 months post procedure
|
0.00%
0/3 • 12 months post procedure
|
10.3%
3/29 • Number of events 3 • 12 months post procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release at least 60 days prior to publication and that the multi-center results should be published prior to any individual site results unless the multi-center results are not published 2 years after the trial is complete. The only embargo that the sponsor can impose is on the release of confidential information.
- Publication restrictions are in place
Restriction type: OTHER