Paroxysmal Atrial FibrillationNCT05024630
Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension
A study testing Renal artery cryoablation, Pulmonary vein cryoablation and Renal arteriography in people with Paroxysmal Atrial Fibrillation and Hypertension, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The DUAL-ICE study is a single-center, prospective, randomized controlled study. The main purpose is to verify that renal artery cryoablation combined with pulmonary vein cryoablation can reduce the recurrence of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation and substandard… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Hypertension
- What is being tested?
- Renal artery cryoablation, Pulmonary vein cryoablation and Renal arteriography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, and <75 years old, gender is not limited;
- Hypertensive patients with symptomatic paroxysmal atrial fibrillation to be treated by catheter ablation with substandard blood pressure. SBP ≥ 150 mmHg or DBP ≥ 90 mmHg in patients taking at least one antihypertensive drug;
- Agree to participate and sign the informed consent.
Who cannot join
- Cannot accept catheter ablation (such as thrombus in left atrium/left atrial appendage, recent myocardial infarction, stroke, etc.);
- Patients with obvious bleeding tendency or unable to accept postoperative anticoagulation;
- The anteroposterior diameter of left atrium indicated by echocardiography was ≥50mm;
- A history of left atrial surgery or left atrial interventional therapy (including cryo-ablation, radiofrequency ablation, left atrial appendage occlusion, etc.);
- NYHA grade IV congestive heart failure or LVEF <30%;
- patients with valvular atrial fibrillation and secondary atrial fibrillation (such as uncontrolled hyperthyroidism, acute alcoholism, atrial fibrillation after cardiac surgery, etc.);
Show all 23Show fewer
- Patients with typical atrial fluttering or other supraventricular tachycardia (duration greater than 30s) confirmed by preoperative electrocardiogram or dynamic electrocardiogram;
- Severe organic heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;
- Patients with secondary hypertension;
- Uncontrollable pulmonary hypertension;
- Patients with glomerular filtration rate (EGFR) < 45ml/min/1.73m2 or patients with chronic kidney disease, nephrotic syndrome, polycystic kidney disease and other renal diseases were estimated according to MDRD calculation method;
- Renal artery imaging (renal artery CTA) exclusion criteria:
- inability to access the renal vascular system;
- Diameter of renal aorta less than 4 mm or length less than 20 mm;
- Hemodynamic or anatomical renal artery abnormalities or stenosis;
- A history of previous renal artery interventions, including balloon angioplasty or stenting;
- There are multiple unilateral renal aortas leading to the kidney;
- Participated in other clinical studies and not yet enrolled in the group;
- Women who are pregnant, lactating or preparing to become pregnant;
- Life expectancy less than 1 year;
- Other conditions that are not suitable for inclusion in this study as assessed by the researcher, such as mental disorders or psychological disorders;
- A history of acute coronary events or percutaneous coronary stent intervention, a history of stroke or transient ischemic attack, and extensive atherosclerosis with intravascular thrombosis within the last 6 months;
- Patients with ICD implantation history or CRT treatment history.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Atrial fIbrillation reCurrence Among Patients With Paroxysmal Atrial Fibrillation and Uncontrolled hypErtension: the DUAL-ICE Pilot Study
The DUAL-ICE study is a single-center, prospective, randomized controlled study. The main purpose is to verify that renal artery cryoablation combined with pulmonary vein cryoablation can reduce the recurrence of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation and substandard hypertension, and to further verify the clinical significance of one-stop cardio-renal combined cryoablation therapy for hypertension control.
Read the detailed description
Hypertension is a major risk factor for the high morbidity and mortality of cardiovascular diseases in the world. As a common arrhythmia, the autonomic nervous system plays an important role in the occurrence and maintenance of atrial fibrillation [1,2]. Enhancement of central sympathetic nervous system activity and stimulation of the efferent sympathetic nerve of the heart can promote the occurrence and development of atrial fibrillation [3]. Hypertension is an important risk factor for the occurrence of atrial fibrillation, and the incidence of complications such as heart failure, coronary heart disease and left ventricular hypertrophy is increased in patients with atrial fibrillation with poor blood pressure control [4-6]. Therefore, hypertension management in patients with atrial fibrillation is particularly important.
However, a 2014 study of SYMPLICITY HTN-3 with a sample size of 535 people showed that RDN could not significantly reduce blood pressure [10], which put the study of RDN into a dilemma. Since then, researchers have optimized the study design, and some more detailed results have suggested a significant antihypertensive effect of RDN [11-13].
At present, there are few reports on the cryo-ablation of renal sympathetic nerve in the RDN studies, only the case of cryo-ablation of renal artery by Dr.Prochnau et al in Germany in 2014, which is still a technical blank in China [14]. At present, catheter ablation has been widely recognized in the treatment of paroxysmal atrial fibrillation. In terms of patient comfort and efficacy, cryo-ablation promoted in recent years shows greater advantages than radiofrequency ablation, which has the characteristics of less damage to surrounding tissues and faster recovery of vascular endothelial function. Therefore, the application of cryoablation in the field of RDN may be similar to the effect of pulmonary vein ablation. The purpose of our study was to investigate whether renal artery cryoablation combined with pulmonary vein cryoablation reduces the recurrence rate of atrial fibrillation compared with pulmonary vein cryoablation alone.
- Conditions
- Paroxysmal Atrial Fibrillation, Hypertension
- Being tested
- Renal artery cryoablation, Pulmonary vein cryoablation, Renal arteriography
- Keywords
- Renal artery cryoablation, Pulmonary vein cryoablation, One-stop cardio-renal combined cryoablation therapy
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal artery cryoablationProcedure or surgery
Renal denervation were achieved by cryoablation of renal artery with cryoballoon.
Pulmonary vein cryoablationProcedure or surgery
Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.
Renal arteriographyProcedure or surgery
Renal artery was examined by renal arteriography
| Study group | Role | What they receive |
|---|---|---|
| RDN+PVI group | Experimental | The experimental group received renal artery cryoablation and pulmonary vein cryoablation. Pulmonary vein cryoablation was first followed by renal artery cryoablation. Receives: Procedure: Renal artery cryoablation; Procedure: Pulmonary vein cryoablation |
| PVI only group | Sham comparator | The control group received pulmonary vein cryoablation alone. To ensure single blindness, the control group received femoral artery puncture and renal arteriography after cryoablation. Receives: Procedure: Pulmonary vein cryoablation; Procedure: Renal arteriography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
Atrial arrhythmia recurrence (documented atrial fibrillation, atrial tachycardia, or atrial flutter for ≥30 seconds during ambulatory monitoring or for ≥10 seconds on a 12-lead ECG), cardioversion, or use of class I or III antiarrhythmic drugs.
Measured: Within 12 months after procedure (outside the 90-day blanking period).
Secondary outcomes (1)
Differences in office blood pressure
Differences in blood pressure (SBP, DBP) between the two groups at 6 and 12 months after procedure compared to the baseline;
Measured: Within 12 months after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hypertensive patients with symptomatic paroxysmal atrial fibrillation who are to be treated by cryoablation with substandard blood pressure (SBP ≥ 150 mmHg or DBP ≥ 90 mmHg in the clinic with at least one antihypertensive drug)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024630
- Sponsor's protocol ID
- DUAL-ICE
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension. 2009 Oct;54(4):690-7. doi: 10.1161/HYPERTENSIONAHA.108.119883. Epub 2009 Aug 31.
PubMed 19720958Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.
PubMed 19822798Arora R, Ng J, Ulphani J, Mylonas I, Subacius H, Shade G, Gordon D, Morris A, He X, Lu Y, Belin R, Goldberger JJ, Kadish AH. Unique autonomic profile of the pulmonary veins and posterior left atrium. J Am Coll Cardiol. 2007 Mar 27;49(12):1340-8. doi: 10.1016/j.jacc.2006.10.075. Epub 2007 Mar 12.
PubMed 17394967Krahn AD, Manfreda J, Tate RB, Mathewson FA, Cuddy TE. The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Manitoba Follow-Up Study. Am J Med. 1995 May;98(5):476-84. doi: 10.1016/S0002-9343(99)80348-9.
PubMed 7733127Benjamin EJ, Levy D, Vaziri SM, D'Agostino RB, Belanger AJ, Wolf PA. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA. 1994 Mar 16;271(11):840-4.
PubMed 8114238Joshi S, Choi AD, Kamath GS, Raiszadeh F, Marrero D, Badheka A, Mittal S, Steinberg JS. Prevalence, predictors, and prognosis of atrial fibrillation early after pulmonary vein isolation: findings from 3 months of continuous automatic ECG loop recordings. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1089-94. doi: 10.1111/j.1540-8167.2009.01506.x. Epub 2009 Jun 22.
PubMed 19549038Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009 Aug 27;361(9):932-4. doi: 10.1056/NEJMc0904179. No abstract available.
PubMed 19710497Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.
PubMed 24210779Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
PubMed 21093036Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
PubMed 24678939Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.
PubMed 32234534Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
PubMed 29803589Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.
PubMed 29803590Prochnau D, Heymel S, Otto S, Figulla HR, Surber R. Renal denervation with cryoenergy as second-line option is effective in the treatment of resistant hypertension in non-responders to radiofrequency ablation. EuroIntervention. 2014 Sep;10(5):640-5. doi: 10.4244/EIJV10I5A110.
PubMed 25256203Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
PubMed 33197159
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Atrial fIbrillation reCurrence Among Patients With Paroxysmal Atrial Fibrillation and Uncontrolled hypErtension: the DUAL-ICE Pilot Study
- ClinicalTrials.gov ID
- NCT05024630
- Acronym / sponsor ID
- DUAL-ICE
- Conditions
- Paroxysmal Atrial Fibrillation, Hypertension
- Keywords
- Renal artery cryoablation, Pulmonary vein cryoablation, One-stop cardio-renal combined cryoablation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DUAL-ICE study is a single-center, prospective, randomized controlled study. The main purpose is to verify that renal artery cryoablation combined with pulmonary vein cryoablation can reduce the recurrence of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation and substandard hypertension, and to further verify the clinical significance of one-stop cardio-renal combined cryoablation therapy for hypertension control.
Detailed description
Hypertension is a major risk factor for the high morbidity and mortality of cardiovascular diseases in the world. As a common arrhythmia, the autonomic nervous system plays an important role in the occurrence and maintenance of atrial fibrillation [1,2]. Enhancement of central sympathetic nervous system activity and stimulation of the efferent sympathetic nerve of the heart can promote the occurrence and development of atrial fibrillation [3]. Hypertension is an important risk factor for the occurrence of atrial fibrillation, and the incidence of complications such as heart failure, coronary heart disease and left ventricular hypertrophy is increased in patients with atrial fibrillation with poor blood pressure control [4-6]. Therefore, hypertension management in patients with atrial fibrillation is particularly important.
However, a 2014 study of SYMPLICITY HTN-3 with a sample size of 535 people showed that RDN could not significantly reduce blood pressure [10], which put the study of RDN into a dilemma. Since then, researchers have optimized the study design, and some more detailed results have suggested a significant antihypertensive effect of RDN [11-13].
At present, there are few reports on the cryo-ablation of renal sympathetic nerve in the RDN studies, only the case of cryo-ablation of renal artery by Dr.Prochnau et al in Germany in 2014, which is still a technical blank in China [14]. At present, catheter ablation has been widely recognized in the treatment of paroxysmal atrial fibrillation. In terms of patient comfort and efficacy, cryo-ablation promoted in recent years shows greater advantages than radiofrequency ablation, which has the characteristics of less damage to surrounding tissues and faster recovery of vascular endothelial function. Therefore, the application of cryoablation in the field of RDN may be similar to the effect of pulmonary vein ablation. The purpose of our study was to investigate whether renal artery cryoablation combined with pulmonary vein cryoablation reduces the recurrence rate of atrial fibrillation compared with pulmonary vein cryoablation alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Hypertensive patients with symptomatic paroxysmal atrial fibrillation who are to be treated by cryoablation with substandard blood pressure (SBP ≥ 150 mmHg or DBP ≥ 90 mmHg in the clinic with at least one antihypertensive drug)
| Arm | Type | Receives |
|---|---|---|
| RDN+PVI group | Experimental | Procedure: Renal artery cryoablation, Procedure: Pulmonary vein cryoablationThe experimental group received renal artery cryoablation and pulmonary vein cryoablation. Pulmonary vein cryoablation was first followed by renal artery cryoablation. |
| PVI only group | Sham comparator | Procedure: Pulmonary vein cryoablation, Procedure: Renal arteriographyThe control group received pulmonary vein cryoablation alone. To ensure single blindness, the control group received femoral artery puncture and renal arteriography after cryoablation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old, and <75 years old, gender is not limited;
- Hypertensive patients with symptomatic paroxysmal atrial fibrillation to be treated by catheter ablation with substandard blood pressure. SBP ≥ 150 mmHg or DBP ≥ 90 mmHg in patients taking at least one antihypertensive drug;
- Agree to participate and sign the informed consent.
Key exclusion criteria (23 listed)
- Cannot accept catheter ablation (such as thrombus in left atrium/left atrial appendage, recent myocardial infarction, stroke, etc.);
- Patients with obvious bleeding tendency or unable to accept postoperative anticoagulation;
- The anteroposterior diameter of left atrium indicated by echocardiography was ≥50mm;
- A history of left atrial surgery or left atrial interventional therapy (including cryo-ablation, radiofrequency ablation, left atrial appendage occlusion, etc.);
- NYHA grade IV congestive heart failure or LVEF <30%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal artery cryoablationRenal denervation were achieved by cryoablation of renal artery with cryoballoon. | Procedure or surgery | RDN+PVI group |
| Pulmonary vein cryoablationPulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon. | Procedure or surgery | PVI only group, RDN+PVI group |
| Renal arteriographyRenal artery was examined by renal arteriography | Procedure or surgery | PVI only group |
Primary outcome
Recurrence of atrial fibrillation
Time frame: Within 12 months after procedure (outside the 90-day blanking period).
Atrial arrhythmia recurrence (documented atrial fibrillation, atrial tachycardia, or atrial flutter for ≥30 seconds during ambulatory monitoring or for ≥10 seconds on a 12-lead ECG), cardioversion, or use of class I or III antiarrhythmic drugs.
1 secondary outcome
Differences in office blood pressure
Time frame: Within 12 months after procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 19720958Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension. 2009 Oct;54(4):690-7. doi: 10.1161/HYPERTENSIONAHA.108.119883. Epub 2009 Aug 31.
- Background: PubMed 19822798Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.
- Background: PubMed 17394967Arora R, Ng J, Ulphani J, Mylonas I, Subacius H, Shade G, Gordon D, Morris A, He X, Lu Y, Belin R, Goldberger JJ, Kadish AH. Unique autonomic profile of the pulmonary veins and posterior left atrium. J Am Coll Cardiol. 2007 Mar 27;49(12):1340-8. doi: 10.1016/j.jacc.2006.10.075. Epub 2007 Mar 12.
- Background: PubMed 7733127Krahn AD, Manfreda J, Tate RB, Mathewson FA, Cuddy TE. The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Manitoba Follow-Up Study. Am J Med. 1995 May;98(5):476-84. doi: 10.1016/S0002-9343(99)80348-9.
- Background: PubMed 8114238Benjamin EJ, Levy D, Vaziri SM, D'Agostino RB, Belanger AJ, Wolf PA. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA. 1994 Mar 16;271(11):840-4.
- Background: PubMed 19549038Joshi S, Choi AD, Kamath GS, Raiszadeh F, Marrero D, Badheka A, Mittal S, Steinberg JS. Prevalence, predictors, and prognosis of atrial fibrillation early after pulmonary vein isolation: findings from 3 months of continuous automatic ECG loop recordings. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1089-94. doi: 10.1111/j.1540-8167.2009.01506.x. Epub 2009 Jun 22.
- Background: PubMed 19710497Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009 Aug 27;361(9):932-4. doi: 10.1056/NEJMc0904179. No abstract available.
- Background: PubMed 24210779Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.
- Background: PubMed 21093036Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
- Background: PubMed 24678939Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
- Background: PubMed 32234534Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.
- Background: PubMed 29803589Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal artery cryoablation, Pulmonary vein cryoablation and Renal arteriography in people with Paroxysmal Atrial Fibrillation and Hypertension, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (18917686332, yizshcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial fibrillation (time frame: Within 12 months after procedure (outside the 90-day blanking period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024630, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.