NCT02115100: ASAF

Treatment of Atrial Fibrillation in Patients by Pulmonary Vein Isolation in Combination With Renal Denervation or Pulmonary Vein Isolation Only

Completed NA Last updated 12 July 2022

What this trial tests

NA trial testing procedure in Paroxysmal Atrial Fibrillation in 145 participants. Completed in 19 January 2022.

Timeline

18 March 2014

Primary endpoint
19 January 2022

19 January 2022

Quick facts

Lead sponsor	Diagram B.V.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	145
Start date	18 March 2014
Primary completion	19 January 2022
Estimated completion	19 January 2022
Sites	8 locations across Netherlands, Spain

Drugs / interventions tested

• procedure

Conditions studied

• Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
• Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
• Out of Range Hypertension — all drugs for Out of Range Hypertension →
• Signs of Sympathetic Overdrive — all drugs for Signs of Sympathetic Overdrive →

Sponsor

Diagram B.V. — full company profile →

Who can join

Adults 18 to 65, any sex, with Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prospective, randomized, controlled, multicenter, international clinical trial. The study population consist of patients with paroxysmal or persistent atrial fibrillation with out range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of the following two groups.

group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo pulmonary vein isolation and renal artery denervation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proceedings from the 3rd European Clinical Consensus Conference for clinical trials in device-based hypertension therapies.
   Mahfoud F, Azizi M, Ewen S, Pathak A, et al · · 2020 · cited 69× · PMID 32211888 · DOI 10.1093/eurheartj/ehaa121
2. Neuroscientific therapies for atrial fibrillation.
   Hanna P, Buch E, Stavrakis S, Meyer C, et al · · 2021 · cited 52× · PMID 33989382 · DOI 10.1093/cvr/cvab172
3. Neuromodulation for the Treatment of Heart Rhythm Disorders.
   Waldron NH, Fudim M, Mathew JP, Piccini JP. · · 2019 · cited 38× · PMID 31468010 · DOI 10.1016/j.jacbts.2019.02.009
4. Atrial fibrillation reduction by renal sympathetic denervation: 12 months' results of the AFFORD study.
   Feyz L, Theuns DA, Bhagwandien R, Strachinaru M, et al · · 2019 · cited 35× · PMID 30413869 · DOI 10.1007/s00392-018-1391-3
5. Iron Deficiency in Pulmonary Arterial Hypertension: A Deep Dive into the Mechanisms.
   Quatredeniers M, Mendes-Ferreira P, Santos-Ribeiro D, Nakhleh MK, et al · · 2021 · cited 31× · PMID 33672218 · DOI 10.3390/cells10020477
6. Renal denervation for resistant hypertension.
   Coppolino G, Pisano A, Rivoli L, Bolignano D. · · 2017 · cited 22× · PMID 28220472 · DOI 10.1002/14651858.cd011499.pub2
7. Neuromodulation therapy for atrial fibrillation.
   Karatela MF, Fudim M, Mathew JP, Piccini JP. · · 2023 · cited 17× · PMID 35988908 · DOI 10.1016/j.hrthm.2022.08.011
8. Renal denervation for resistant hypertension.
   Pisano A, Iannone LF, Leo A, Russo E, et al · · 2021 · cited 14× · PMID 34806762 · DOI 10.1002/14651858.cd011499.pub3