Trial Outcomes & Findings for Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation (NCT NCT01420393)
NCT ID: NCT01420393
Last Updated: 2026-05-11
Results Overview
Heart failure event defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
411 participants
Primary outcome timeframe
Baseline to study completion, an average of 24 months
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
Rhythm Control
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
Rhythm control: Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
|
Rate Control
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
Rate Control: Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
197
|
|
Overall Study
COMPLETED
|
209
|
186
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
Rhythm Control
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
Rhythm control: Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
|
Rate Control
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
Rate Control: Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Cardiac Transplant
|
0
|
2
|
Baseline Characteristics
Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Rhythm Control
n=214 Participants
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
Rhythm control: Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
|
Rate Control
n=197 Participants
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
Rate Control: Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
NT-proBNP
|
1583 pg/mL
n=44 Participants
|
1689 pg/mL
n=10 Participants
|
1636 pg/mL
n=30 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=44 Participants
|
56 Participants
n=10 Participants
|
135 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
135 Participants
n=44 Participants
|
141 Participants
n=10 Participants
|
276 Participants
n=30 Participants
|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 8.6 • n=44 Participants
|
67.5 years
STANDARD_DEVIATION 8.0 • n=10 Participants
|
66.7 years
STANDARD_DEVIATION 8.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=44 Participants
|
49 Participants
n=10 Participants
|
106 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=44 Participants
|
148 Participants
n=10 Participants
|
305 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=44 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
204 Participants
n=44 Participants
|
193 Participants
n=10 Participants
|
397 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=30 Participants
|
|
Region of Enrollment
Canada
|
206 participants
n=44 Participants
|
192 participants
n=10 Participants
|
398 participants
n=30 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=44 Participants
|
3 participants
n=10 Participants
|
6 participants
n=30 Participants
|
|
Region of Enrollment
Taiwan
|
3 participants
n=44 Participants
|
0 participants
n=10 Participants
|
3 participants
n=30 Participants
|
|
Region of Enrollment
Brazil
|
2 participants
n=44 Participants
|
2 participants
n=10 Participants
|
4 participants
n=30 Participants
|
|
6 Minute walk distance
|
344.4 metres
STANDARD_DEVIATION 107.1 • n=44 Participants
|
363.1 metres
STANDARD_DEVIATION 101.4 • n=10 Participants
|
353.75 metres
STANDARD_DEVIATION 104.25 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion, an average of 24 monthsHeart failure event defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Outcome measures
| Measure |
Rhythm Control
n=214 Participants
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
Rhythm control: Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
|
Rate Control
n=197 Participants
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
Rate Control: Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
|
|---|---|---|
|
Composite of All-cause Mortality and Heart Failure Events
|
50 Participants
|
64 Participants
|
Adverse Events
Rhythm Control
Serious events: 88 serious events
Other events: 66 other events
Deaths: 29 deaths
Rate Control
Serious events: 73 serious events
Other events: 68 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Rhythm Control
n=214 participants at risk
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
|
Rate Control
n=197 participants at risk
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
|
|---|---|---|
|
Cardiac disorders
Pericardial Effusion
|
2.8%
6/214 • Baseline to study completion
|
0.00%
0/197 • Baseline to study completion
|
|
General disorders
Major bleed
|
3.7%
8/214 • Baseline to study completion
|
0.00%
0/197 • Baseline to study completion
|
|
General disorders
Minor bleed
|
2.3%
5/214 • Baseline to study completion
|
0.00%
0/197 • Baseline to study completion
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/214 • Baseline to study completion
|
2.0%
4/197 • Baseline to study completion
|
|
General disorders
Amiodarone-induced toxicity
|
0.00%
0/214 • Baseline to study completion
|
0.51%
1/197 • Baseline to study completion
|
|
General disorders
Stroke
|
2.3%
5/214 • Baseline to study completion
|
2.5%
5/197 • Baseline to study completion
|
|
Cardiac disorders
CV hospitalizaton
|
30.8%
66/214 • Baseline to study completion
|
34.5%
68/197 • Baseline to study completion
|
|
Cardiac disorders
Ablation related hospitalizations
|
10.7%
23/214 • Baseline to study completion
|
0.51%
1/197 • Baseline to study completion
|
|
Cardiac disorders
Device implant related
|
0.47%
1/214 • Baseline to study completion
|
2.0%
4/197 • Baseline to study completion
|
|
Cardiac disorders
AV node ablation hospitalizations
|
0.47%
1/214 • Baseline to study completion
|
0.00%
0/197 • Baseline to study completion
|
|
General disorders
Total Hospitalizations
|
41.1%
88/214 • Number of events 261 • Baseline to study completion
|
37.1%
73/197 • Number of events 233 • Baseline to study completion
|
|
Cardiac disorders
Atrioesophageal fistula
|
0.47%
1/214 • Baseline to study completion
|
0.00%
0/197 • Baseline to study completion
|
Other adverse events
| Measure |
Rhythm Control
n=214 participants at risk
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
|
Rate Control
n=197 participants at risk
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR \< 80 bpm and 6-minute walk HR \< 110 bpm.
|
|---|---|---|
|
General disorders
NON CV hospitalizations
|
30.8%
66/214 • Baseline to study completion
|
34.5%
68/197 • Baseline to study completion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place